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Trial record 14 of 173 for:    pertuzumab

A Multiple-Dose Study of RhuMab 2C4 and Docetaxel in the Treatment of Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02490475
Recruitment Status : Completed
First Posted : July 3, 2015
Results First Posted : November 25, 2015
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Solid Tumor
Interventions Drug: Docetaxel
Drug: RhuMab 2C4
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description Participants received 60 milligrams per square meter (mg/m^2) docetaxel and 1050 mg of pertuzumab as an intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 hours (h) apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Period Title: Period 1: First 6 Cycles
Started 6 2 6 5
Completed 0 0 0 0
Not Completed 6 2 6 5
Reason Not Completed
Adverse Event             2             1             0             1
Insufficient Therapeutic Response             2             0             2             2
Refused Treatment             1             0             0             0
Completed 6 Cycles of Therapy             1             1             4             2
Period Title: Period 2: Extension Phase
Started 1 0 3 1
Completed 0 0 0 0
Not Completed 1 0 3 1
Reason Not Completed
Insufficient Therapeutic Response             1             0             2             0
Refused Treatment             0             0             0             1
Adverse Event             0             0             1             0
Arm/Group Title Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420 Total
Hide Arm/Group Description Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Total of all reporting groups
Overall Number of Baseline Participants 6 2 6 5 19
Hide Baseline Analysis Population Description
The Intent-To-Treat (ITT) Population included all participants who received any amount of the study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 2 participants 6 participants 5 participants 19 participants
58.2  (5.38) 62.5  (9.19) 59.5  (6.06) 45.0  (20.21) 55.6  (12.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 6 participants 5 participants 19 participants
Female
2
  33.3%
0
   0.0%
1
  16.7%
3
  60.0%
6
  31.6%
Male
4
  66.7%
2
 100.0%
5
  83.3%
2
  40.0%
13
  68.4%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Docetaxel in Combination of Pertuzumab
Hide Description A prior dose level was defined as an MTD if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs). If there were no DLTs or DLTs were seen in less than (<) 2 participants in the highest dose level, that was considered as MTD. Participants received escalating doses of docetaxel and pertuzumab until DLTs were observed. DLTs were defined as any of the following: 1) Any non-hematological toxicity ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.
Time Frame Cycle 1 Up to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
Participants received escalating dose levels of combination of docetaxel and pertuzumab. Participants received docetaxel 60 mg/m^2 and pertuzumab 1050 mg at dose level 1, docetaxel 75 mg/m^2 and pertuzumab 1050 mg at dose level 2, docetaxel 75 mg/m^2 and pertuzumab 420 mg at dose level 3 or 100 mg/m^2 and pertuzumab 420 mg at dose level 4 until DLTs were observed.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: mg/m^2
75.0
2.Secondary Outcome
Title Plasma Decay Half Life (t1/2) for Pertuzumab in Combination With Docetaxel
Time Frame Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. number (n) equals (=) number of participants analyzed at the specified timepoint for each arm, respectively.
Arm/Group Title Pertuzumab 1050 Pertuzumab 840 Pertuzumab 420
Hide Arm/Group Description:
Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Overall Number of Participants Analyzed 8 11 10
Median (Full Range)
Unit of Measure: days
Cycle 1 (n=8,11,0)
12.65
(7.80 to 19.59)
11.65
(6.95 to 25.96)
NA [1] 
(NA to NA)
Cycle 2 (n=7,0,10)
19.02
(9.02 to 49.63)
NA [2] 
(NA to NA)
18.46
(8.85 to 42.00)
[1]
Participants received 420 mg of pertuzumab only in Cycle 2 per dose regimen.
[2]
Participants received 840 mg of pertuzumab only in Cycle 1 per dose regimen.
3.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) for Pertuzumab in Combination With Docetaxel
Hide Description Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as micrograms per milliliter (μg/mL).
Time Frame Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. n = number of participants analyzed at the specified timepoint for each arm, respectively.
Arm/Group Title Pertuzumab 1050 Pertuzumab 840 Pertuzumab 420
Hide Arm/Group Description:
Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Overall Number of Participants Analyzed 8 11 10
Mean (Standard Deviation)
Unit of Measure: μg/mL
Cycle 1 (n=8,11,0) 301.0  (93.0) 255.0  (84.0) NA [1]   (NA)
Cycle 2 (n=7,0,10) 368.0  (79.0) NA [2]   (NA) 150.0  (43.0)
[1]
Participants received 420 mg of pertuzumab only in Cycle 2 per dose regimen.
[2]
Participants received 840 mg of pertuzumab only in Cycle 1 per dose regimen.
4.Secondary Outcome
Title Area Under the Concentration Curve From Time Zero to the Last Visit (AUC [0-last]) for Pertuzumab in Combination With Docetaxel
Hide Description The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (μg*day/mL).
Time Frame Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description

ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.

n = number of participants analyzed at the specified timepoint for each arm, respectively.

Arm/Group Title Pertuzumab 1050 Pertuzumab 840 Pertuzumab 420
Hide Arm/Group Description:
Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Overall Number of Participants Analyzed 8 11 10
Mean (Standard Deviation)
Unit of Measure: μg*day/mL
Cycle 1 (n=8,11,0) 2390  (584) 1749  (543) NA [1]   (NA)
Cycle 2 (n=7,0,10) 3500  (551) NA [2]   (NA) 1491  (472)
[1]
Participants received 420 mg of pertuzumab only in Cycle 2 per dose regimen.
[2]
Participants received 840 mg of pertuzumab only in Cycle 1 per dose regimen.
5.Secondary Outcome
Title AUC From Time Zero to Infinity (AUC [0-infinity]) for Pertuzumab in Combination With Docetaxel
Hide Description The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as μg*day/mL.
Time Frame Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description

ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.

n = number of participants analyzed at the specified timepoint for each arm, respectively.

Arm/Group Title Pertuzumab 1050 Pertuzumab 840 Pertuzumab 420
Hide Arm/Group Description:
Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Overall Number of Participants Analyzed 8 11 10
Mean (Standard Deviation)
Unit of Measure: μg*day/mL
Cycle 1 (n=8,11,0) 3951  (919) 2796  (967) NA [1]   (NA)
Cycle 2 (n=7,0,10) 6856  (2335) NA [2]   (NA) 2762  (892)
[1]
Participants received 420 mg of pertuzumab only in Cycle 2 per dose regimen
[2]
Participants received 840 mg of pertuzumab only in Cycle 1 per dose regimen.
6.Secondary Outcome
Title Clearance (Cl) of Pertuzimab in Combination With Docetaxel
Hide Description Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).
Time Frame Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description

ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.

n = number of participants analyzed at the specified timepoint for each arm, respectively.

Arm/Group Title Pertuzumab 1050 Pertuzumab 840 Pertuzumab 420
Hide Arm/Group Description:
Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Overall Number of Participants Analyzed 8 11 10
Mean (Standard Deviation)
Unit of Measure: mL/day
Cycle 1 (n=8,11,0) 282  (83) 329  (97) NA [1]   (NA)
Cycle 2 (n=7,0,10) 167  (49) NA [2]   (NA) 169  (60)
[1]
Participants received 420 mg of pertuzumab only in Cycle 2 per dose regimen.
[2]
Participants received 840 mg of pertuzumab only in Cycle 1 per dose regimen.
7.Secondary Outcome
Title Volume of Distribution (Vz) at Steady State of Pertuzumab in Combination With Docetaxel
Hide Description The volume of distribution at steady state (Vz), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.
Time Frame Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description

ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.

n = number of participants analyzed at the specified timepoint for each arm, respectively.

Arm/Group Title Pertuzumab 1050 Pertuzumab 840 Pertuzumab 420
Hide Arm/Group Description:
Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Overall Number of Participants Analyzed 8 11 10
Mean (Standard Deviation)
Unit of Measure: mL
Cycle 1 (n=8,11,0) 5214  (1386) 5355  (1680) NA [1]   (NA)
Cycle 2 (n=7,0,10) 4672  (1221) NA [2]   (NA) 4233  (1555)
[1]
Participants received 420 mg of pertuzumab only in Cycle 2 per dose regimen.
[2]
Participants received 840 mg of pertuzumab only in Cycle 1 per dose regimen.
8.Secondary Outcome
Title Mean Residence Time (MRT) of Pertuzumab
Hide Description MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.
Time Frame Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description

ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.

n = number of participants analyzed at the specified timepoint for each arm, respectively.

Arm/Group Title Pertuzumab 1050 Pertuzumab 840 Pertuzumab 420
Hide Arm/Group Description:
Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
Overall Number of Participants Analyzed 8 11 10
Mean (Standard Deviation)
Unit of Measure: days
Cycle 1 (n=8,11,0) 17.8  (5.8) 15.8  (6.7) NA [1]   (NA)
Cycle 2 (n=7,0,10) 29.5  (18.5) NA [2]   (NA) 25.8  (13.2)
[1]
Participants received 420 mg of pertuzumab only in Cycle 2 per dose regimen.
[2]
Participants received 840 mg of pertuzumab only in Cycle 1 per dose regimen.
9.Secondary Outcome
Title Percentage of Participants by Best Overall Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Hide Description Best Overall response was evaluated as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). CR: complete disappearance of all target lesions. PR: at least a 30 percent (%) decrease in the sum of the longest diameters. SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameters since the treatment started. PD: at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.
Time Frame Weeks 7 (Cycle 2),13 (Cycle 4) and Final Visit Up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n = number of participants still receiving treatment at the specified cycle for each arm respectively.
Arm/Group Title Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 2 6 5
Measure Type: Number
Unit of Measure: percentage of participants
Cycle 2: CR (n=6,1,6,4) 0.0 0.0 0.0 0.0
Cycle 2:PR (n=6,1,6,4) 0.0 0.0 0.0 0.0
Cycle 2:SD (n=6,1,6,4) 83.3 100.0 83.3 75.0
Cycle 2:PD (n=6,1,6,4) 16.7 0 16.7 25.0
Cycle 2:Missing (n=6,1,6,4) 0.0 0.0 0.0 0.0
Cycle 4:CR (n=5,1,5,3) 0.0 0.0 0.0 0.0
Cycle 4:PR (n=5,1,5,3) 0.0 0.0 20.0 0
Cycle 4:SD (n=5,1,5,3) 80.0 100.0 40.0 66.7
Cycle 4:PD (n=5,1,5,3) 20.0 0.0 40.0 33.3
Cycle 4:Missing (n=5,1,5,3) 0.0 0.0 0.0 0.0
Final visit:CR (n=6,2,6,5) 0.0 0.0 0.0 0.0
Final visit:PR (n=6,2,6,5) 0.0 0.0 16.7 0.0
Final visit:SD (n=6,2,6,5) 33.3 50.0 33.3 20.0
Final visit:PD (n=6,2,6,5) 50.0 0.0 50.0 60.0
Final visit:Missing (n=6,2,6,5) 16.7 50.0 0.0 20.0
10.Secondary Outcome
Title Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) by Category of Decrease and Timepoint
Hide Description Ejection fraction (EF) is the fraction of outbound blood pumped from the heart with each heartbeat. It is commonly measured by echocardiogram and serves as a general measure of a person's cardiac function. Changes in LVEF were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria. The decrease in LVEF has been categorized as follows: A) Increase, no change, decrease from baseline less than (<) 10%; B) Absolute value <50% and decrease from baseline greater than or equal to (≥) 10%; C) Absolute value <50% and decrease from baseline≥15% ; D) Other. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.
Time Frame Baseline, Weeks 7(Cycle 2), 13 (Cycle 4) and Final Visit Up to Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n = number of participants still receiving treatment at the specified cycle for each arm, respectively.
Arm/Group Title Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 2 6 5
Measure Type: Number
Unit of Measure: percentage of participants
Cycle 2: A (n=6,1,6,4) 83.3 100.0 100.0 100.0
Cycle 2: B (n=6,1,6,4) 0.0 0.0 0.0 0.0
Cycle 2: C (n=6,1,6,4) 0.0 0.0 0.0 0.0
Cycle 2: D (n=6,1,6,4) 16.7 0.0 0.0 0.0
Cycle 4: A (n=5,1,4,3) 100.0 100.0 75.0 100.0
Cycle 4: B (n=5,1,4,3) 0.0 0.0 25.0 0.0
Cycle 4: C (n=5,1,4,3) 0.0 0.0 0.0 0.0
Cycle 4: D (n=5,1,4,3) 0.0 0.0 0.0 0.0
Final Visit: A (n=3,1,5,2) 66.7 100.0 80.0 100.0
Final Visit: B (n=3,1,5,2) 0.0 0.0 0.0 0.0
Final Visit: C (n=3,1,5,2) 0.0 0.0 0.0 0.0
Final Visit: D (n=3,1,5,2) 33.3 0.0 20.0 0.0
11.Secondary Outcome
Title t1/2 for Docetaxel Alone and in Combination With Pertuzumab
Hide Description The biological half-life or terminal half-life of docetaxel is the time in hours it takes for it to lose half of its pharmacologic activity. Data for "docetaxel alone" arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.
Time Frame Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.
Arm/Group Title Docetaxel 60 Alone Docetaxel 60 + Pertuzumab 1050 Docetaxel 75 Alone Docetaxel 75+ Pertuzumab 420 Docetaxel 100 Alone Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 6 6 6 5 4
Median (Full Range)
Unit of Measure: days
Cycle 1 (n=6,0,6,0,5,0)
17.7
(7.31 to 22.7)
NA [1] 
(NA to NA)
12.0
(9.56 to 19.4)
NA [1] 
(NA to NA)
8.92
(7.49 to 13.5)
NA [1] 
(NA to NA)
Cycle 2(n=0,6,0,6,0,4)
NA [2] 
(NA to NA)
19.7
(12.5 to 27.1)
NA [2] 
(NA to NA)
13.8
(9.62 to 23.8)
NA [2] 
(NA to NA)
11.8
(8.04 to 21.4)
[1]
In Cycle 1 analysis was performed for docetaxel alone data on pertuzumab naive participants only.
[2]
Data were not analyzed for docetaxel alone since participants were already exposed to pertuzumab in Cycle 1.
12.Secondary Outcome
Title Tmax for Docetaxel Alone and in Combination With Pertuzumab
Hide Description Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; Data for "docetaxel alone" arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. When the rate of absorption equals the rate of elimination. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.
Time Frame Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.
Arm/Group Title Docetaxel 60 Alone Docetaxel 60 + Pertuzumab 1050 Docetaxel 75 Alone Docetaxel 75 + Pertuzumab 420 Docetaxel 100 Alone Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 6 6 6 5 4
Median (Full Range)
Unit of Measure: days
Cycle 1 (n=6,0,6,0,5,0)
0.50
(0.50 to 0.90)
NA [1] 
(NA to NA)
0.50
(0.50 to 0.90)
NA [1] 
(NA to NA)
0.90
(0.90 to 0.90)
NA [1] 
(NA to NA)
Cycle 2 (n=0,6,0,6,0,4)
NA [2] 
(NA to NA)
0.90
(0.50 to 1.25)
NA [2] 
(NA to NA)
0.90
(0.50 to 0.90)
NA [2] 
(NA to NA)
0.70
(0.50 to 0.90)
[1]
In Cycle 1 analysis was performed for docetaxel alone data on pertuzumab naive participants only.
[2]
Data were not analyzed for docetaxel alone since participants were already exposed to pertuzumab in Cycle 1.
13.Secondary Outcome
Title Cmax for Docetaxel Alone and in Combination With Pertuzumab
Hide Description Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.
Time Frame Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.
Arm/Group Title Docetaxel 60 Alone Docetaxel 60 + Pertuzumab 1050 Docetaxel 75 Alone Docetaxel 75 + Pertuzumab 420 Docetaxel 100 Alone Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 6 6 6 5 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 (n=6,0,6,0,5,0) 1642  (274) NA [1]   (NA) 3128  (895) NA [1]   (NA) 5450  (1867) NA [1]   (NA)
Cycle 2 (n=0,6,0,6,0,4) NA [2]   (NA) 1695  (331) NA [2]   (NA) 2722  (912) NA [2]   (NA) 4705  (1871)
[1]
In Cycle 1 analysis was performed for docetaxel alone data on pertuzumab naive participants only.
[2]
Data were not analyzed for docetaxel alone since participants were already exposed to pertuzumab in Cycle 1.
14.Secondary Outcome
Title AUC(0-∞) for Docetaxel Alone and in Combination With Pertuzumab
Hide Description The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as ng*h/mL. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.
Time Frame Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.
Arm/Group Title Docetaxel 60 Alone Docetaxel 60 + Pertuzumab 1050 Docetaxel 75 Alone Docetaxel 75 + Pertuzumab 420 Docetaxel 100 Alone Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 6 6 6 5 4
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Cycle 1 (n=6,0,6,0,5,0) 1838  (244) NA [1]   (NA) 3744  (1304) NA [1]   (NA) 5930  (2137) NA [1]   (NA)
Cycle 2 (n=0,6,0,6,0,4) NA [2]   (NA) 1734  (409) NA [2]   (NA) 3496  (1211) NA [2]   (NA) 5218  (2216)
[1]
In Cycle 1 analysis was performed for docetaxel alone data on pertuzumab naive participants only.
[2]
Data were not analyzed for docetaxel alone since participants were already exposed to pertuzumab in Cycle 1.
15.Secondary Outcome
Title Vss for Docetaxel Alone and in Combination With Pertuzumab
Hide Description The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.
Time Frame Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.
Arm/Group Title Docetaxel 60 Alone Docetaxel 60 + Pertuzumab 1050 Docetaxel 75 Alone Docetaxel 75 + Pertuzumab 420 Docetaxel 100 Alone Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 6 6 6 5 4
Mean (Standard Deviation)
Unit of Measure: mL/m^2
Cycle 1 (n=6,0,6,0,5,0) 786981  (218139) NA [1]   (NA) 410174  (184216) NA [1]   (NA) 254233  (85054) NA [1]   (NA)
Cycle 2 (n=0,6,0,6,0,4) NA [2]   (NA) 1023569  (335711) NA [2]   (NA) 566759  (361946) NA [2]   (NA) 428863  (283977)
[1]
In Cycle 1 analysis was performed for docetaxel alone data on pertuzumab naive participants only.
[2]
Data were not analyzed for docetaxel alone since participants were already exposed to pertuzumab in Cycle 1.
16.Secondary Outcome
Title CL for Docetaxel Alone and in Combination With Pertuzumab
Hide Description Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per hour per meter squared (mL/h/m^2). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.
Time Frame Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.
Arm/Group Title Docetaxel 60 Alone Docetaxel 60 + Pertuzumab 1050 Docetaxel 75 Alone Docetaxel 75 + Pertuzumab 420 Docetaxel 100 Alone Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 6 6 6 5 4
Mean (Standard Deviation)
Unit of Measure: mL/h/m^2
Cycle 1 (n=6,0,6,0,5,0) 33128  (4396) NA [1]   (NA) 22013  (7031) NA [1]   (NA) 18913  (7245) NA [1]   (NA)
Cycle 2 (n=0,6,0,6,0,4) NA [2]   (NA) 35813  (6216) NA [2]   (NA) 23747  (8175) NA [2]   (NA) 22976  (12679)
[1]
In Cycle 1 analysis was performed for docetaxel alone data on pertuzumab naive participants only.
[2]
Data were not analyzed for docetaxel alone since participants were already exposed to pertuzumab in Cycle 1.
17.Secondary Outcome
Title Number of Participants With DLTs
Hide Description DLTs were defined as any of the following: 1) Any non-hematological toxicity greter than or equal to (≥) Grade 3 according t0 CTCAE version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.
Time Frame From Baseline until 4 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description:
Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
Overall Number of Participants Analyzed 6 2 6 5
Measure Type: Number
Unit of Measure: number of participants
0 2 0 2
Time Frame Adverse events were continuously monitored from Screening until 4 weeks after the final visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420
Hide Arm/Group Description Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication. Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
All-Cause Mortality
Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   2/2 (100.00%)   0/6 (0.00%)   3/5 (60.00%) 
Blood and lymphatic system disorders         
Febrile neutropenia * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  1/5 (20.00%) 
Gastrointestinal disorders         
Diarrhoea * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/5 (0.00%) 
Nausea * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Vomiting * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
General disorders         
Fatigue * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/5 (0.00%) 
Pyrexia * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Infections and infestations         
Lower respiratory tract infection * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Urinary tract infection * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Nervous system disorders         
Paralysis * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Vascular disorders         
Hypertension * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel 60 Plus (+) Pertuzumab 1050 Docetaxel 75 + Pertuzumab 1050 Docetaxel 75 + Pertuzumab 420 Docetaxel 100 + Pertuzumab 420
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   2/2 (100.00%)   6/6 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/5 (20.00%) 
Lymph node pain * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Cardiac disorders         
Ventricular disfunction * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Eye disorders         
Lacrimation * 1  1/6 (16.67%)  0/2 (0.00%)  2/6 (33.33%)  1/5 (20.00%) 
Conjunctivitis * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Diplopia * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Dry eye * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Visual acuity reduced * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Gastrointestinal disorders         
Diarrhoea * 1  5/6 (83.33%)  2/2 (100.00%)  5/6 (83.33%)  4/5 (80.00%) 
Nausea * 1  5/6 (83.33%)  2/2 (100.00%)  5/6 (83.33%)  4/5 (80.00%) 
Abdominal pain * 1  4/6 (66.67%)  0/2 (0.00%)  0/6 (0.00%)  2/5 (40.00%) 
Dyspepsia * 1  2/6 (33.33%)  0/2 (0.00%)  2/6 (33.33%)  2/5 (40.00%) 
Mouth ulceration * 1  2/6 (33.33%)  0/2 (0.00%)  3/6 (50.00%)  0/5 (0.00%) 
Stomatitis * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  3/5 (60.00%) 
Vomiting * 1  1/6 (16.67%)  0/2 (0.00%)  1/6 (16.67%)  2/5 (40.00%) 
Constipation * 1  2/6 (33.33%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Abdominal pain upper * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Haemorrhoids * 1  2/6 (33.33%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Proctalgia * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Abdominal discomfort * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Abdominal pain lower * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Anal fissure * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Ascites * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Gastrooesophageal reflux disease * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Gingivitis * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Glossitis * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Oesophagitis * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Proctitis * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Tongue ulceration * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/5 (0.00%) 
Toothache * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
General disorders         
Fatigue * 1  5/6 (83.33%)  2/2 (100.00%)  6/6 (100.00%)  5/5 (100.00%) 
Mucosal inflammation * 1  2/6 (33.33%)  0/2 (0.00%)  2/6 (33.33%)  1/5 (20.00%) 
Malaise * 1  2/6 (33.33%)  0/2 (0.00%)  1/6 (16.67%)  1/5 (20.00%) 
Oedema peripheral * 1  1/6 (16.67%)  0/2 (0.00%)  1/6 (16.67%)  1/5 (20.00%) 
Chest pain * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Chills * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  2/5 (40.00%) 
Extravasation * 1  1/6 (16.67%)  1/2 (50.00%)  0/6 (0.00%)  0/5 (0.00%) 
Pyrexia * 1  2/6 (33.33%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Injection site haemorrhage * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Pain * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Suprapubic pain * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/5 (0.00%) 
Infections and infestations         
Lower respiratory tract infection * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  2/5 (40.00%) 
Nasopharyngitis * 1  2/6 (33.33%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Oral candidiasis * 1  1/6 (16.67%)  0/2 (0.00%)  1/6 (16.67%)  1/5 (20.00%) 
Upper respiratory tract infection * 1  2/6 (33.33%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Candidiasis * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/5 (0.00%) 
Cystitis * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Eye infection * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Localised infection * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Respiratory tract infection * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Urinary tract infection * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Investigations         
Alanine aminotransferase increased * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/5 (0.00%) 
Weight decreased * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Metabolism and nutrition disorders         
Anorexia * 1  2/6 (33.33%)  0/2 (0.00%)  2/6 (33.33%)  1/5 (20.00%) 
Decreased appetite * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  2/6 (33.33%)  0/2 (0.00%)  4/6 (66.67%)  1/5 (20.00%) 
Pain in extremity * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  2/5 (40.00%) 
Back pain * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Chest wall pain * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Flank pain * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Limb discomfort * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Myalgia * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Neck pain * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Shoulder pain * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer pain * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Nervous system disorders         
Dysgeusia * 1  4/6 (66.67%)  1/2 (50.00%)  4/6 (66.67%)  0/5 (0.00%) 
Headache * 1  1/6 (16.67%)  0/2 (0.00%)  2/6 (33.33%)  2/5 (40.00%) 
Paraesthesia * 1  1/6 (16.67%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Ageusia * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Dizziness * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Hypoaesthesia * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Neuropathy * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Neuropathy peripheral * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Somnolence * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Syncope * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Psychiatric disorders         
Insomnia * 1  0/6 (0.00%)  0/2 (0.00%)  2/6 (33.33%)  1/5 (20.00%) 
Depression * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Anxiety * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Confusional state * 1  0/6 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/5 (0.00%) 
Renal and urinary disorders         
Dysuria * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Urinary incontinence * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Reproductive system and breast disorders         
Gential Haemorrhage * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis * 1  1/6 (16.67%)  0/2 (0.00%)  5/6 (83.33%)  1/5 (20.00%) 
Cough * 1  2/6 (33.33%)  0/2 (0.00%)  1/6 (16.67%)  1/5 (20.00%) 
Dyspnoea * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  2/5 (40.00%) 
Pharyngolaryngeal pain * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  2/5 (40.00%) 
Rhinorrhoea * 1  2/6 (33.33%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Throat irritation * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/5 (20.00%) 
Nasal mucosal disorder * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Productive cough * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  0/6 (0.00%)  0/2 (0.00%)  5/6 (83.33%)  4/5 (80.00%) 
Rash * 1  4/6 (66.67%)  0/2 (0.00%)  2/6 (33.33%)  2/5 (40.00%) 
Nail disorder * 1  1/6 (16.67%)  0/2 (0.00%)  2/6 (33.33%)  1/5 (20.00%) 
Erythema * 1  1/6 (16.67%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Acne * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Drug eruption * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Dry skin * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Erythema multiforme * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Hyperhidrosis * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Periorbital oedema * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Rash follicular * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Rash papular * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Skin disorder * 1  1/6 (16.67%)  0/2 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Vascular disorders         
Hypertension * 1  0/6 (0.00%)  1/2 (50.00%)  1/6 (16.67%)  1/5 (20.00%) 
Flushing * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Hot flush * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Lymphoedema * 1  0/6 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/5 (0.00%) 
Phlebitis * 1  0/6 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02490475     History of Changes
Other Study ID Numbers: BO17021
First Submitted: July 2, 2015
First Posted: July 3, 2015
Results First Submitted: July 28, 2015
Results First Posted: November 25, 2015
Last Update Posted: May 17, 2017