Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 87 of 172 for:    pertuzumab

Safety and Efficacy Study of Pertuzumab to Treat Castration-Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00058539
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : June 23, 2015
Last Update Posted : June 23, 2015
Sponsor:
Information provided by:
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: rhuMAb 2C4 (pertuzumab)
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab
Hide Arm/Group Description All the participants received a loading dose of 840 milligrams (mg) of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an intravenous (IV) infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Period Title: Overall Study
Started 42
Completed 0
Not Completed 42
Reason Not Completed
Disease progression             24
Adverse Event             3
Withdrawal by Subject             5
Physician Decision             9
Death             1
Arm/Group Title Pertuzumab
Hide Arm/Group Description All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
All the participants who received at least 1 dose of study drug were included in the analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
67.7  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
0
   0.0%
Male
41
 100.0%
1.Primary Outcome
Title Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
Hide Description Response by tumor measurement occurred if there was documented and confirmed CR or PR. Response was assessed by both the RECIST and by PSA levels measurement, based on measurable or non-measurable disease at baseline. Per RECIST, CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A PSA response was defined as a PSA decline of greater than or equal to (≥) 50%, which had to be confirmed by a second PSA value at least 4 weeks later.
Time Frame Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population: All participants who received at least 1 dose of study drug and either underwent at least 1 postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 0.0)
2.Primary Outcome
Title Kaplan Meier Estimate of Percentage of Participants With Disease Progression at 3 Months
Hide Description Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of participants
80
3.Secondary Outcome
Title Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])
Hide Description PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with an event divided by the number of participants analyzed, multiplied by 100.
Time Frame Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population. Five participants were censored for this analysis.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of participants
83.3
4.Secondary Outcome
Title Median Time of PFS
Hide Description PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.
Time Frame Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population. Five participants were censored for this analysis.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: weeks
9.6
(9.1 to 11.1)
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time from the initial CR or PR to the time of disease progression.
Time Frame Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab
Hide Outcome Measure Data
Hide Analysis Population Description
No participants experienced either CR or PR.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Participants Who Progressed at 3, 6 and 9 Months
Hide Description Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of participants who were free from disease progression was calculated by subtracting the number of participants with disease progression at that time point from the total population at risk of disease progression, multiplied by 100.
Time Frame 3, 6, and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of participants
% of participants progressed at 3 months 66.7
% of participants progressed at 6 months 80.0
% of participants progressed at 9 months 83.3
7.Secondary Outcome
Title Serum Concentrations of Pertuzumab
Hide Description [Not Specified]
Time Frame Assessed at pre-dose, 15-minutes postdose on Day 1 (Cycle 1), Day 22 (Cycle 2), Day 43 (Cycle 3), Day 85 (Cycle 5), and Day 169 (Cycle 9); pre-dose on Day 253 (Cycle 13), and on Days 8, 15, 29 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic evaluable participants
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (µg/mL)
Day 1, 15 minutes postdose (n=38) 254.71  (46.85)
Day 8 (n=39) 97.51  (25.93)
Day 15 (n=38) 69.23  (19.13)
Day 22 pre-dose (n=33) 52.41  (15.23)
Day 22, 15 minutes postdose (n=31) 175.87  (34.70)
Day 29 (n=30) 88.17  (27.83)
Day 36 (n=32) 67.45  (21.46)
Day 43 pre-dose (n=26) 53.09  (19.45)
Day 43, 15 minutes postdose (n=23) 176.17  (32.43)
Day 85 pre-dose (n=5) 67.36  (23.66)
Day 85, 15 minutes postdose (n=4) 199.50  (35.07)
Day 169 pre-dose (n=3) 75.97  (49.41)
Day 169, 15 minutes postdose (n=3) 207.67  (71.70)
Day 253 pre-dose (n=1) 40.7 [1]   (NA)
[1]
Standard deviation was not analyzed for single participant.
Time Frame Adverse events were collected from baseline until up to 30 days after the last dose of pertuzumab.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pertuzumab
Hide Arm/Group Description All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
All-Cause Mortality
Pertuzumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab
Affected / at Risk (%)
Total   11/41 (26.83%) 
Cardiac disorders   
Tachycardia * 1  1/41 (2.44%) 
Gastrointestinal disorders   
Constipation * 1  1/41 (2.44%) 
Duodenal ulcer haemorrhage * 1  1/41 (2.44%) 
Ileus * 1  1/41 (2.44%) 
General disorders   
Pain * 1  1/41 (2.44%) 
Infections and infestations   
Cellulitis * 1  1/41 (2.44%) 
Pneumonia * 1  1/41 (2.44%) 
Injury, poisoning and procedural complications   
Stent occlusion * 1  1/41 (2.44%) 
Investigations   
Troponin t increased * 1  1/41 (2.44%) 
Musculoskeletal and connective tissue disorders   
Bone pain * 1  2/41 (4.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastatic pain * 1  1/41 (2.44%) 
Nervous system disorders   
Neuropathy * 1  1/41 (2.44%) 
Renal and urinary disorders   
Ureteric obstruction * 1  2/41 (4.88%) 
Bilateral hydronephrosis * 1  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  1/41 (2.44%) 
Vascular disorders   
Deep vein thrombosis * 1  1/41 (2.44%) 
*
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
Affected / at Risk (%)
Total   39/41 (95.12%) 
Blood and lymphatic system disorders   
Anaemia * 1  4/41 (9.76%) 
Gastrointestinal disorders   
Diarrhoea * 1  25/41 (60.98%) 
Nausea * 1  14/41 (34.15%) 
Constipation * 1  8/41 (19.51%) 
Vomiting * 1  8/41 (19.51%) 
Abdominal Pain * 1  4/41 (9.76%) 
Stomatitis * 1  3/41 (7.32%) 
General disorders   
Fatigue * 1  14/41 (34.15%) 
Oedema peripheral * 1  8/41 (19.51%) 
Mucosal inflammation * 1  6/41 (14.63%) 
Pain * 1  6/41 (14.63%) 
Asthenia * 1  5/41 (12.20%) 
Pyrexia * 1  5/41 (12.20%) 
Infections and infestations   
Upper respiratory tract infection * 1  5/41 (12.20%) 
Urinary tract infection * 1  4/41 (9.76%) 
Rhinitis * 1  3/41 (7.32%) 
Sinusitis * 1  3/41 (7.32%) 
Investigations   
Ejection fraction decreased * 1  12/41 (29.27%) 
Activated partial thromboplastin time prolonged * 1  3/41 (7.32%) 
Prothrombin time prolonged * 1  3/41 (7.32%) 
Weight decreased * 1  3/41 (7.32%) 
Metabolism and nutrition disorders   
Anorexia * 1  11/41 (26.83%) 
Decreased appetite * 1  4/41 (9.76%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  13/41 (31.71%) 
Myalgia * 1  7/41 (17.07%) 
Neck pain * 1  5/41 (12.20%) 
Back pain * 1  4/41 (9.76%) 
Chest wall pain * 1  4/41 (9.76%) 
Pain in extremity * 1  4/41 (9.76%) 
Muscular weakness * 1  3/41 (7.32%) 
Nervous system disorders   
Hypoaesthesia * 1  5/41 (12.20%) 
Dizziness * 1  3/41 (7.32%) 
Renal and urinary disorders   
Dysuria * 1  6/41 (14.63%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  6/41 (14.63%) 
Rhinorrhoea * 1  4/41 (9.76%) 
Cough * 1  3/41 (7.32%) 
Skin and subcutaneous tissue disorders   
Rash * 1  7/41 (17.07%) 
Dry skin * 1  3/41 (7.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.0)
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-LaRoche
Phone: : 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00058539     History of Changes
Obsolete Identifiers: NCT00066755
Other Study ID Numbers: TOC2682g
First Submitted: April 8, 2003
First Posted: April 9, 2003
Results First Submitted: June 2, 2015
Results First Posted: June 23, 2015
Last Update Posted: June 23, 2015