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Trial record 17 of 172 for:    pertuzumab

A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02494596
Recruitment Status : Completed
First Posted : July 10, 2015
Results First Posted : September 30, 2015
Last Update Posted : November 10, 2015
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: Capecitabine
Drug: RhuMab 2C4
Enrollment 19
Recruitment Details  
Pre-assignment Details Participants were grouped into three cohorts and received either 825 mg, 1000 mg or 1250 mg capecitabine to determine the maximum tolerated dose.
Arm/Group Title Capecitabine 825 Plus (+) Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Hide Arm/Group Description Participants received a single dose of capecitabine 825 milligrams per square meter (mg/m^2) orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent. Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent. Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Period Title: Overall Study
Started 5 7 7
Completed 2 2 6
Not Completed 3 5 1
Reason Not Completed
Insufficient Therapeutic Response             3             3             1
Adverse Event             0             1             0
Refused Treatment             0             1             0
Arm/Group Title Capecitabine + Pertuzumab
Hide Arm/Group Description Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
The Intent-To-Treat (ITT) Population included all participants who received any amount of the study medication. The baseline analysis population represents participants from all three cohorts.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
60.9  (9.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
11
  61.1%
Male
7
  38.9%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine
Hide Description MTD was defined as the highest tolerated dose combination of capecitabine (825 mg, 1000 mg or 1250 mg) and pertuzumab, without causing Dose Limiting Toxicities (DLTs). DLTs were defined as follows: 1) Any non-hematological toxicity greater than or equal to (≥) 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 > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT. MTD was measured in mg/m^2.
Time Frame Cycle 1 (3 Weeks)
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Hide Analysis Population Description
The 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 Capecitabine + Pertuzumab
Hide Arm/Group Description:
Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: mg/m^2
1250
2.Secondary Outcome
Title Percentage of Participants With DLTs
Hide Description DLTs were defined as follows: 1)Any non-hematological toxicity greater than or equal to (≥) 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 > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT.
Time Frame Cycle 1 (3 Weeks)
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Hide Analysis Population Description
Safety population
Arm/Group Title Capecitabine 825 Plus (+) Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Hide Arm/Group Description:
Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 5 6 7
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
3.Secondary Outcome
Title Plasma Half-Life (t1/2) of Pertuzumab
Time Frame Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and Predose on Days 8, 15 and 22
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine + Pertuzumab
Hide Arm/Group Description:
Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: days
14.6  (41.0)
4.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of 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 was measured as nanograms per milliliter (ng/mL).
Time Frame Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine + Pertuzumab
Hide Arm/Group Description:
Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ng/mL
355111  (59051)
5.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of Pertuzumab
Hide Description Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. Tmax was measured in days.
Time Frame Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine + Pertuzumab
Hide Arm/Group Description:
Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: days
0.137  (0.076)
6.Secondary Outcome
Title Area Under the Concentration Curve From Time Zero to Last Measurement (AUC 0-last) of Pertuzumab
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 was measured as ng*day/mL.
Time Frame Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine + Pertuzumab
Hide Arm/Group Description:
Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ng*day/mL
2742561  (743598)
7.Secondary Outcome
Title AUC From Time Zero to Infinity (AUC 0-infinity) of 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 nanograms times days per milliliter (ng*day/mL).
Time Frame Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine + Pertuzumab
Hide Arm/Group Description:
Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ng*day/mL
4096501  (1282130)
8.Secondary Outcome
Title Apparent Volume of Distribution of 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. Vss was measured in mL
Time Frame Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine + Pertuzumab
Hide Arm/Group Description:
Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mL
5202  (1007)
9.Secondary Outcome
Title Apparent Total Clearance of 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 day (mL/day).
Time Frame Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine + Pertuzumab
Hide Arm/Group Description:
Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mL/day
283.0  (98.0)
10.Secondary Outcome
Title Plasma Half-Life of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab
Hide Description Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5’-deoxy-5-fluorocytidine (5'-DFCR), 5’-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). The biological half-life or terminal half-life is the time in days it takes for it to lose half of its pharmacologic activity.
Time Frame Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine 825 + Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Hide Arm/Group Description:
Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 5 6 7
Mean (Standard Deviation)
Unit of Measure: hours
Capecitabine Alone 5'-DFCR 0.89  (0.27) 0.82  (0.28) 0.82  (0.23)
Capecitabine Alone 5'-DFUR 0.75  (0.26) 0.76  (0.23) 0.66  (0.09)
Capecitabine Alone 5-FU 0.67  (0.22) 0.64  (0.13) 0.70  (0.16)
Capecitabine Alone Capecitabine 0.54  (0.19) 0.40  (0.10) 0.36  (0.11)
Capecitabine Alone FBAL 2.54  (0.30) 2.69  (0.39) 3.08  (0.78)
Capecitabine + Pertuzumab 5'-DFCR 0.78  (0.38) 0.76  (0.18) 0.75  (0.14)
Capecitabine + Pertuzumab 5'-DFUR 0.62  (0.13) 0.73  (0.21) 0.79  (0.28)
Capecitabine + Pertuzumab 5-FU 0.73  (0.40) 0.67  (0.14) 0.80  (0.35)
Capecitabine + Pertuzumab Capecitabine 0.42  (0.14) 0.62  (0.28) 0.54  (0.28)
Capecitabine + Pertuzumab FBAL 2.59  (0.64) 2.58  (0.57) 2.81  (0.44)
11.Secondary Outcome
Title Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab
Hide Description Capecitabine is an oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety 5-FU in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5'-DFCR, 5'-DFUR, and FBAL. 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).
Time Frame Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine 825 + Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Hide Arm/Group Description:
Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 5 6 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
Capecitabine Alone 5'-DFCR 4508  (2317) 7687  (1443) 8647  (3254)
Capecitabine Alone 5'-DFUR 5274  (1832) 7657  (2708) 10311  (3323)
Capecitabine Alone 5-FU 201  (94) 355  (119) 369  (107)
Capecitabine Alone Capecitabine 4802  (3159) 9112  (6189) 7543  (2944)
Capecitabine Alone FBAL 3214  (396) 3963  (947) 5290  (576)
Capecitabine + Pertuzumab 5'-DFCR 4909  (2518) 3917  (1411) 6569  (2827)
Capecitabine + Pertuzumab 5'-DFUR 5736  (1831) 4103  (1595) 8683  (4142)
Capecitabine + Pertuzumab 5-FU 219  (106) 187  (92) 345  (214)
Capecitabine + Pertuzumab Capecitabine 8060  (4800) 3367  (1741) 4731  (3198)
Capecitabine + Pertuzumab FBAL 3674  (1121) 3498  (809) 5136  (843)
12.Secondary Outcome
Title Time to Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab
Hide Description Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5’-deoxy-5-fluorocytidine (5'-DFCR), 5’-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination.
Time Frame Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose
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Hide Analysis Population Description
ITT population
Arm/Group Title Capecitabine 825 + Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Hide Arm/Group Description:
Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 5 6 7
Mean (Standard Deviation)
Unit of Measure: hours
Capecitabine Alone 5'-DFCR 1.3  (0.66) 0.82  (0.26) 1.05  (0.51)
Capecitabine Alone 5'-DFUR 1.3  (0.66) 0.76  (0.49) 1.05  (0.51)
Capecitabine Alone 5-FU 1.3  (0.66) 0.64  (0.49) 1.05  (0.51)
Capecitabine Alone Capecitabine 1.2  (0.75) 0.4  (0.28) 0.77  (0.35)
Capecitabine Alone FBAL 2.4  (0.55) 2.69  (0.41) 2.21  (0.40)
Capecitabine + Pertuzumab 5'-DFCR 0.9  (0.65) 1.42  (0.66) 1.86  (1.32)
Capecitabine + Pertuzumab 5'-DFUR 1.0  (0.61) 2.0  (1.10) 1.86  (1.32)
Capecitabine + Pertuzumab 5-FU 0.9  (0.65) 1.84  (1.17) 1.93  (1.24)
Capecitabine + Pertuzumab Capecitabine 0.7  (0.28) 1.17  (0.40) 1.15  (0.62)
Capecitabine + Pertuzumab FBAL 2.6  (0.90) 3.16  (1.17) 2.50  (1.39)
Time Frame Adverse events were recorded continuously from Day -7 until 4 weeks after the final visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine 825 + Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Hide Arm/Group Description Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent. Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent. Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
All-Cause Mortality
Capecitabine 825 + Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine 825 + Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   1/6 (16.67%)   1/7 (14.29%) 
Gastrointestinal disorders       
Intestinal Obstruction * 1  0/5 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary Embolism * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
*
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%
Capecitabine 825 + Pertuzumab 1050 Capecitabine 1000 + Pertuzumab 1050 Capecitabine 1250 + Pertuzumab 1050
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   6/6 (100.00%)   7/7 (100.00%) 
Eye disorders       
Keratoconjunctivitis sicca * 1  0/5 (0.00%)  0/6 (0.00%)  4/7 (57.14%) 
Gastrointestinal disorders       
Diarrhoea * 1  3/5 (60.00%)  3/6 (50.00%)  7/7 (100.00%) 
Nausea * 1  4/5 (80.00%)  4/6 (66.67%)  4/7 (57.14%) 
Vomiting * 1  2/5 (40.00%)  3/6 (50.00%)  2/7 (28.57%) 
Abdominal pain upper * 1  0/5 (0.00%)  2/6 (33.33%)  2/7 (28.57%) 
Constipation * 1  0/5 (0.00%)  0/6 (0.00%)  3/7 (42.86%) 
Haemorrhoids * 1  1/5 (20.00%)  0/6 (0.00%)  1/7 (14.29%) 
Abdominal distension * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Cheilitis * 1  0/5 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Dyspepsia * 1  0/5 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Flatulence * 1  0/5 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Glossitis * 1  0/5 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Lip dry * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Odynophagia * 1  0/5 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Oral pain * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Stomatitis * 1  0/5 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Toothache * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
General disorders       
Asthenia * 1  1/5 (20.00%)  3/6 (50.00%)  4/7 (57.14%) 
Mucosal inflammation * 1  0/5 (0.00%)  2/6 (33.33%)  4/7 (57.14%) 
Pyrexia * 1  0/5 (0.00%)  2/6 (33.33%)  2/7 (28.57%) 
Oedema Peripheral * 1  2/5 (40.00%)  0/6 (0.00%)  0/7 (0.00%) 
Catheter site pain * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Chest pain * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Chills * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Feeling hot * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Infections and infestations       
Influenza * 1  2/5 (40.00%)  0/6 (0.00%)  1/7 (14.29%) 
Herpes simplex * 1  0/5 (0.00%)  0/6 (0.00%)  2/7 (28.57%) 
Rhinitis * 1  0/5 (0.00%)  0/6 (0.00%)  2/7 (28.57%) 
Upper respiratory tract infection * 1  0/5 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Investigations       
Blood bilirubin increased * 1  1/5 (20.00%)  1/6 (16.67%)  0/7 (0.00%) 
Haematocrit decreased * 1  1/5 (20.00%)  1/6 (16.67%)  0/7 (0.00%) 
Metabolism and nutrition disorders       
Anorexia * 1  2/5 (40.00%)  3/6 (50.00%)  4/7 (57.14%) 
Decreased appetite * 1  1/5 (20.00%)  1/6 (16.67%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders       
Ligament disorder * 1  1/5 (20.00%)  0/6 (0.00%)  1/7 (14.29%) 
Arthralgia * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Joint swelling * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Pain in extremity * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Nervous system disorders       
Lethargy * 1  2/5 (40.00%)  2/6 (33.33%)  2/7 (28.57%) 
Dizziness * 1  0/5 (0.00%)  0/6 (0.00%)  2/7 (28.57%) 
Dysgeusia * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Paraesthesia * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Psychiatric disorders       
Insomnia * 1  0/5 (0.00%)  0/6 (0.00%)  3/7 (42.86%) 
Depressed mood * 1  1/5 (20.00%)  1/6 (16.67%)  0/7 (0.00%) 
Anxiety * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Confusional state * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders       
Dysuria * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Micturition disorder * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Pollakiuria * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Reproductive system and breast disorders       
Metrorrhagia * 1  1/5 (20.00%)  0/6 (0.00%)  1/7 (14.29%) 
Pelvic pain * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/5 (20.00%)  1/6 (16.67%)  0/7 (0.00%) 
Pleuritic pain * 1  0/5 (0.00%)  2/6 (33.33%)  0/7 (0.00%) 
Productive cough * 1  0/5 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Dyspnoea * 1  1/5 (20.00%)  0/6 (0.00%)  0/7 (0.00%) 
Epistaxis * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Rhinorrhoea * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Skin and subcutaneous tissue disorders       
Skin reaction * 1  2/5 (40.00%)  0/6 (0.00%)  2/7 (28.57%) 
Erythema * 1  1/5 (20.00%)  1/6 (16.67%)  1/7 (14.29%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  0/5 (0.00%)  0/6 (0.00%)  3/7 (42.86%) 
Rash * 1  0/5 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Blister * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Pruritus * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Vascular disorders       
Hypotension * 1  0/5 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Haemorrhage * 1  0/5 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
*
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: NCT02494596     History of Changes
Other Study ID Numbers: BO17003
First Submitted: July 8, 2015
First Posted: July 10, 2015
Results First Submitted: July 30, 2015
Results First Posted: September 30, 2015
Last Update Posted: November 10, 2015