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A Study of Pertuzumab in Participants With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02480010
Recruitment Status : Terminated (The study was terminated at the time of interim analysis since none of the participants showed a PSA response.)
First Posted : June 24, 2015
Results First Posted : September 18, 2015
Last Update Posted : September 18, 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 Prostate Cancer
Intervention Drug: Pertuzumab
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab 420 Milligrams (mg) - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description Participants in Cohort A received an intravenous (IV) loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination. Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Period Title: Overall Study
Started 35 33
Completed 0 0
Not Completed 35 33
Reason Not Completed
Adverse Event             3             1
Death             1             0
Insufficient therapeutic response             31             29
Refused Treatment             0             3
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B Total
Hide Arm/Group Description Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination. Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination. Total of all reporting groups
Overall Number of Baseline Participants 35 33 68
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population consisted of all participants enrolled and who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 33 participants 68 participants
70.8  (7.45) 71.2  (6.01) 71.0  (6.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 68 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
35
 100.0%
33
 100.0%
68
 100.0%
1.Primary Outcome
Title Percentage of Participants With Confirmed, Objective Response, Non-Response or Progressive Disease by PSA Levels Within the First 24 Weeks of Treatment With Pertuzumab
Hide Description Objective PSA response rate was determined according to Prostate Specific Antigen Working Group (PSAWG) guidelines. All participants achieving a drop in PSA of greater than or equal to (≥) 50 percent (%) from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria of a PSA response. The confirmatory second value had to be at least 50% lower than baseline, but could be higher than the first drop in PSA. Confirmatory value could not be 50% higher compared to first drop in PSA. The date of response was the date the first 50% (or greater) decline was observed. Progressive disease (PD) was defined by a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which documented progressively increasing values. Non-response was defined as neither PD nor Response.
Time Frame Screening, Every 3 weeks up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 33
Measure Type: Number
Unit of Measure: percentage of participants
Objective response 0.0 0.0
Non-response 34.3 30.3
PD 65.7 66.7
Missing 0.0 3.0
2.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events. 1) PSA progression as defined by the PSAWG, 2) Evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 3) One bone scan at least 6 months subsequent to baseline demonstrating 2 or more new skeletal lesions and 4) An event due to metastatic prostate cancer requiring intervention.
Time Frame Screening, Every 3 weeks up to a maximum of 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: weeks
5.6
(2.8 to 20.9)
6.1
(2.7 to 17.9)
3.Secondary Outcome
Title Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Hide Description Overall objective response by RECIST criteria (CR or PR) was to be defined for participants who had measurable disease at baseline or developed new lesions post-baseline. The longest diameter only for all target lesions was measured and the following responses recorded: CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter as compared to the baseline sum longest diameter.
Time Frame Screening, Weeks 6, 12, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Response
Hide Description Time to response was the date of the first documentation of PSA response.
Time Frame Screening, Every 3 weeks for a maximum of 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Duration of Response According to PSA Levels
Hide Description Duration of PSA Response was measured from first 50% decline in PSA compared to baseline until the time at which there was an increase of ≥50% from the PSA nadir, provided the absolute increase was at least 5 nanograms per milliliter (ng/ml). The increase must have been confirmed by a second consecutive measurement that was at least 50% above the nadir.
Time Frame Baseline, Every 3 weeks for a maximum of 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Duration of Response According to RECIST Criteria
Hide Description For participants with measurable disease, duration of response was defined as first documentation of tumor response, either a PR or CR, to first documentation of PD or death. Participants who never progressed or died were censored at their last tumor measurement.
Time Frame Baseline, Weeks 6, 12, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percentage of Participants Without Progression
Hide Description Disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Non-progression included participants who had responded plus those who had not responded and not progressed within the first 3 cycles.
Time Frame Screening, Weeks 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 33
Measure Type: Number
Unit of Measure: percentage of participants
20.0 18.2
8.Secondary Outcome
Title Time to Prostate Cancer Pain Progression
Hide Description Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events: 1) Opioid therapy, 2) Radiation therapy, 3) Glucocorticoid therapy, 4) Radionuclide therapy or 5) Chemotherapy.
Time Frame Every 3 weeks up to a maximum of 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the interval of time in weeks between start of treatment and day of death. Participants who did not die while being followed were censored at the last time that they were known to be alive.
Time Frame Screening, Every 3 weeks up to a maximum of 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed due to early termination of the study.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to Treatment Failure was time to the first documentation of progressive disease, day of death while on study (or 30 days after withdrawing from the trial) or day of early discontinuation due to toxicity (adverse events or abnormal laboratory value), refusal of treatment/refusing to cooperate/withdrawing consent, insufficient therapeutic response, or failure to return, whichever is earliest, after the start of treatment. Participants who did not experience any of the above events while on study were censored on the day of their last PSA or tumor measurement, whichever was later.
Time Frame Every 3 weeks up to a maximum of 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 33
Median (Full Range)
Unit of Measure: days
6.1
(2.8 to 20.9)
6.1
(2.7 to 17.9)
11.Secondary Outcome
Title Change From Baseline in Bone Alkaline Phosphatase
Hide Description Bone alkaline phosphatase (BAP) is the bone-specific isoform of alkaline phosphatase. Serum Bone alkaline phosphatase is used to measure osteoporosis and is measured as units per liter (u/L).
Time Frame Screening, Weeks 6, 12, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed to due to early termination of the study.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline in N-Telopeptide
Hide Description In bone physiology, the N-terminal telopeptide (or more formally, amino-terminal collagen crosslinks, and known by the acronym NTX) is a telopeptide that can be used as a biomarker to measure the rate of bone turnover. NTX can be measured in the urine (uNTX) or serum (serum NTX).
Time Frame Screening, Weeks 6, 12, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed to due to early termination of the study.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Area Under the Concentration Curve Extrapolated to Infinity (AUC0-Inf) 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-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 micrograms times days per milliliter (µg*day/mL)
Time Frame Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with non-missing data were included in the analysis.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*day/mL
3488
(44%)
5097
(71%)
14.Secondary Outcome
Title AUC to Last Measurable Concentration (AUC0-last) of Pertuzumab
Hide Description 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.
Time Frame Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*day/mL
2305
(22%)
2626
(28%)
15.Secondary Outcome
Title Maximum Plasma Concentration of Pertuzumab
Hide Description Cmax is the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. Cmax is measured as micrograms per mL (μg/mL).
Time Frame Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
255
(23%)
294
(24%)
16.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of Pertuzumab
Hide Description Cmax refers to the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. tmax is the time at which the Cmax is observed.
Time Frame Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1 and on Days 8 and 15, Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: days
0.073
(11%)
0.074
(6%)
17.Secondary Outcome
Title Terminal Elimination Half-Life (t1/2) of Pertuzumab
Hide Description t1/2 is the time in days required for the concentration of the drug to reach half of its original value
Time Frame Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with non-missing data were included in the analysis.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: days
13.7
(39%)
19.3
(69%)
18.Secondary Outcome
Title Serum 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 Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with non-missing data were included in the analysis.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/day
270
(29%)
253
(35%)
19.Secondary Outcome
Title Volume of Distribution at Steady State 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.
Time Frame Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with non-missing data were included in the analysis.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL
4452
(26%)
5227
(24%)
20.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 Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with non-missing data were included in the analysis.
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description:
Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
Overall Number of Participants Analyzed 35 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: days
18.1
(42%)
25.7
(77%)
Time Frame Adverse Events were recorded from the date of Screening until 7 weeks after the last infusion of study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Hide Arm/Group Description Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination. Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
All-Cause Mortality
Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   9/35 (25.71%)   6/33 (18.18%) 
Blood and lymphatic system disorders     
Anemia * 1  1/35 (2.86%)  0/33 (0.00%) 
Hematolytic Uremic Syndrome * 1  1/35 (2.86%)  0/33 (0.00%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/35 (2.86%)  0/33 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  0/35 (0.00%)  1/33 (3.03%) 
Hemastemisis * 1  0/35 (0.00%)  1/33 (3.03%) 
Ileus Paralytic * 1  0/35 (0.00%)  1/33 (3.03%) 
Nausea * 1  0/35 (0.00%)  1/33 (3.03%) 
General disorders     
Oedema Peripheral * 1  1/35 (2.86%)  0/33 (0.00%) 
Infections and infestations     
Central Line Infection * 1  0/35 (0.00%)  1/33 (3.03%) 
Sepsis * 1  0/35 (0.00%)  1/33 (3.03%) 
Investigations     
Electrocardiogram wave Inversions * 1  1/35 (2.86%)  0/33 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycemia * 1  1/35 (2.86%)  0/33 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic Pain * 1  0/35 (0.00%)  1/33 (3.03%) 
Nervous system disorders     
Cauda Equina Syndrome * 1  1/35 (2.86%)  0/33 (0.00%) 
Renal and urinary disorders     
Urinary retention * 1  3/35 (8.57%)  0/33 (0.00%) 
Renal Failure * 1  1/35 (2.86%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  1/35 (2.86%)  0/33 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis * 1  0/35 (0.00%)  1/33 (3.03%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pertuzumab 420 mg - Cohort A Pertuzumab 1050 mg - Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   28/35 (80.00%)   24/33 (72.73%) 
Blood and lymphatic system disorders     
Anaemia * 1  4/35 (11.43%)  0/33 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  18/35 (51.43%)  17/33 (51.52%) 
Nausea * 1  11/35 (31.43%)  2/33 (6.06%) 
Constipation * 1  3/35 (8.57%)  1/33 (3.03%) 
Flatulence * 1  3/35 (8.57%)  1/33 (3.03%) 
Vomiting * 1  4/35 (11.43%)  0/33 (0.00%) 
Abdominal Pain Upper * 1  2/35 (5.71%)  1/33 (3.03%) 
General disorders     
Fatigue * 1  15/35 (42.86%)  4/33 (12.12%) 
Asthenia * 1  3/35 (8.57%)  2/33 (6.06%) 
Pyrexia * 1  3/35 (8.57%)  1/33 (3.03%) 
Influenza Like Illnes * 1  2/35 (5.71%)  0/33 (0.00%) 
Infections and infestations     
Rhinitis * 1  3/35 (8.57%)  2/33 (6.06%) 
Nasopharyngitis * 1  3/35 (8.57%)  0/33 (0.00%) 
Urinary Tract Infection * 1  2/35 (5.71%)  1/33 (3.03%) 
Investigations     
Ejection Fraction Decreased * 1  2/35 (5.71%)  1/33 (3.03%) 
Metabolism and nutrition disorders     
Anorexia * 1  8/35 (22.86%)  2/33 (6.06%) 
Musculoskeletal and connective tissue disorders     
Backpain * 1  5/35 (14.29%)  2/33 (6.06%) 
Pain in Extremity * 1  3/35 (8.57%)  4/33 (12.12%) 
Arhralgia * 1  2/35 (5.71%)  2/33 (6.06%) 
Bone Pain * 1  2/35 (5.71%)  0/33 (0.00%) 
Buttock Pain * 1  2/35 (5.71%)  0/33 (0.00%) 
Nervous system disorders     
Dysguesia * 1  4/35 (11.43%)  1/33 (3.03%) 
Headache * 1  3/35 (8.57%)  1/33 (3.03%) 
Hypoaesthesia * 1  2/35 (5.71%)  2/33 (6.06%) 
Paraesthesia * 1  2/35 (5.71%)  1/33 (3.03%) 
Renal and urinary disorders     
Haematuria * 1  4/35 (11.43%)  0/33 (0.00%) 
Dysuria * 1  2/35 (5.71%)  0/33 (0.00%) 
Urinary Retention * 1  2/35 (5.71%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea * 1  3/35 (8.57%)  4/33 (12.12%) 
Cough * 1  4/35 (11.43%)  0/33 (0.00%) 
Epistaxis * 1  2/35 (5.71%)  1/33 (3.03%) 
Dysponea * 1  2/35 (5.71%)  0/33 (0.00%) 
Pharyngnolaryngeal Pain * 1  2/35 (5.71%)  0/33 (0.00%) 
Rhinitis Allergic * 1  2/35 (5.71%)  0/33 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  3/35 (8.57%)  4/33 (12.12%) 
Onychorrhexis * 1  2/35 (5.71%)  0/33 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.0)
The study was terminated at the time of interim analysis since none of the participants showed a PSA response.
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
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02480010     History of Changes
Other Study ID Numbers: BO17004
First Submitted: June 5, 2015
First Posted: June 24, 2015
Results First Submitted: July 22, 2015
Results First Posted: September 18, 2015
Last Update Posted: September 18, 2015