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A Study to Evaluate the Effect of HER2 Activation on rhuMAb 2C4 (Pertuzumab) in Subjects With Advanced Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00058552
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : June 23, 2015
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Intervention Drug: Pertuzumab (rhuMAb 2C4)
Enrollment 129
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description Participants in this group received pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for Cycle 1 (1 Cycle equals to [=] 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression. Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
Period Title: Overall Study
Started 65 64
Completed 0 2
Not Completed 65 62
Reason Not Completed
Died prior to receiving treatment             4             2
Disease progression             52             44
Adverse Event             4             2
Withdrawal by Subject             3             5
Physician Decision             2             5
Clinical disease progression             0             4
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg Total
Hide Arm/Group Description Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression. Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 61 62 123
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 61 participants 62 participants 123 participants
58.1  (9.9) 56.5  (11.2) 57.3  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 123 participants
Female
61
 100.0%
62
 100.0%
123
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or Cancer Antigen 125 (CA-125) Changes
Hide Description Response by tumor measurement occurred if there was documented and confirmed CR or PR determined by 2 consecutive investigator assessments that were at least 28 days apart. Response was assessed by either the RECIST v 1.1 or by CA-125 changes, based on measurable or non-measurable disease at baseline. Per RECIST v 1.1 (for measurable disease), 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 longest diameter. Per CA-125 changes (for non-measurable disease), CR: decrease in the CA-125 to within the normal limits and less than (<) 40 international units per milliliter (IU/mL) and no clinical or radiological evidence of disease, PR: a greater than (>) 50 percent (%) decrease in CA-125 values from baseline, and no clinical or radiological evidence of new lesions.
Time Frame Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (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 one postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
Overall Number of Participants Analyzed 55 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.6
(0.7 to 11.8)
4.8
(1.3 to 12.9)
2.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 event divided by the number of participants analyzed, multiplied by 100.
Time Frame Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
Overall Number of Participants Analyzed 55 62
Measure Type: Number
Unit of Measure: percentage of participants
89.1 75.8
3.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 and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
Overall Number of Participants Analyzed 55 62
Median (95% Confidence Interval)
Unit of Measure: weeks
7.6
(6.0 to 11.4)
6.1
(5.9 to 11.4)
4.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 and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)
Hide Outcome Measure Data
Hide Analysis Population Description
Only responders (CR or PR) were included in the analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
Overall Number of Participants Analyzed 2 3
Median (95% Confidence Interval)
Unit of Measure: weeks
18.6
(17.9 to 19.4)
21.1
(13.1 to 29.1)
5.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.
Time Frame Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
Overall Number of Participants Analyzed 55 62
Measure Type: Number
Unit of Measure: percentage of participants
69.1 46.8
6.Secondary Outcome
Title Overall Survival
Hide Description Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.
Time Frame Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population. Seventeen participants in pertuzumab 420 mg arm and 33 participants in pertuzumab 1050 mg were censored for this analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
Overall Number of Participants Analyzed 55 62
Median (95% Confidence Interval)
Unit of Measure: weeks
46.7
(30.4 to 66.6)
NA [1] 
(38.9 to NA)
[1]
Data for 33 participants were censored, thus median and confidence interval upper limit were not reached.
7.Secondary Outcome
Title Kaplan Meier Estimate of Percentage of Participants Who Were Free of Disease Progression at 3, 6, and 12 Months
Hide Description Per RECIST v 1.1, 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 longest diameter recorded since the treatment started or the appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.
Time Frame 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants in this group received pertuzumab at a loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression (1 Cycle = 3 Weeks).
Participants in this group received 1050 mg of pertuzumab at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
Overall Number of Participants Analyzed 55 62
Measure Type: Number
Unit of Measure: percentage of participants
% of participants free from PD at 3 months 25.5 24.2
% of participants free from PD at 6 months 7.3 6.5
% of participants free from PD at 12 months 0.0 0.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression. Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
All-Cause Mortality
Pertuzumab 420 mg Pertuzumab 1050 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab 420 mg Pertuzumab 1050 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   26/61 (42.62%)   18/62 (29.03%) 
Cardiac disorders     
Atrial fibrillation * 1  1/61 (1.64%)  0/62 (0.00%) 
Cardiac tamponade * 1  0/61 (0.00%)  1/62 (1.61%) 
Endocarditis noninfective * 1  1/61 (1.64%)  0/62 (0.00%) 
Pericardial effusion * 1  0/61 (0.00%)  1/62 (1.61%) 
Gastrointestinal disorders     
Small intestinal obstruction * 1  8/61 (13.11%)  6/62 (9.68%) 
Intestinal obstruction * 1  2/61 (3.28%)  2/62 (3.23%) 
Abdomial pain * 1  2/61 (3.28%)  1/62 (1.61%) 
Ascites * 1  2/61 (3.28%)  0/62 (0.00%) 
Diarrhoea * 1  2/61 (3.28%)  0/62 (0.00%) 
Vomiting * 1  2/61 (3.28%)  0/62 (0.00%) 
Nausea * 1  1/61 (1.64%)  0/62 (0.00%) 
General disorders     
Asthenia * 1  1/61 (1.64%)  0/62 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal * 1  1/61 (1.64%)  0/62 (0.00%) 
Infections and infestations     
Abdominal abscess * 1  1/61 (1.64%)  0/62 (0.00%) 
Influenza * 1  1/61 (1.64%)  0/62 (0.00%) 
Pneumonia * 1  1/61 (1.64%)  0/62 (0.00%) 
Injury, poisoning and procedural complications     
Intestinal stoma complication * 1  1/61 (1.64%)  0/62 (0.00%) 
Investigations     
Ejection fraction decreased * 1  0/61 (0.00%)  1/62 (1.61%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/61 (1.64%)  2/62 (3.23%) 
Hypercalcaemia * 1  0/61 (0.00%)  1/62 (1.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant ascites * 1  1/61 (1.64%)  0/62 (0.00%) 
Malignant pleural effusion * 1  1/61 (1.64%)  0/62 (0.00%) 
Ovarian cancer * 1  0/61 (0.00%)  1/62 (1.61%) 
Renal and urinary disorders     
Bladder pain * 1  0/61 (0.00%)  1/62 (1.61%) 
Bladder spasm * 1  0/61 (0.00%)  1/62 (1.61%) 
Obstructive uropathy * 1  1/61 (1.64%)  0/62 (0.00%) 
Renal failure acute * 1  0/61 (0.00%)  1/62 (1.61%) 
Ureteric obstruction * 1  0/61 (0.00%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  1/61 (1.64%)  2/62 (3.23%) 
Aspiration * 1  2/61 (3.28%)  0/62 (0.00%) 
Pulmonary embolism * 1  0/61 (0.00%)  1/62 (1.61%) 
Vascular disorders     
Thrombosis * 1  1/61 (1.64%)  0/62 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
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 Pertuzumab 1050 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   61/61 (100.00%)   60/62 (96.77%) 
Blood and lymphatic system disorders     
Anaemia * 1  9/61 (14.75%)  10/62 (16.13%) 
Cardiac disorders     
Tachycardia * 1  5/61 (8.20%)  2/62 (3.23%) 
Gastrointestinal disorders     
Diarrhoea * 1  40/61 (65.57%)  45/62 (72.58%) 
Abdominal pain * 1  25/61 (40.98%)  20/62 (32.26%) 
Nausea * 1  22/61 (36.07%)  22/62 (35.48%) 
Vomiting * 1  22/61 (36.07%)  17/62 (27.42%) 
Constipation * 1  17/61 (27.87%)  11/62 (17.74%) 
Abdominal distention * 1  13/61 (21.31%)  8/62 (12.90%) 
Dyspepsia * 1  6/61 (9.84%)  13/62 (20.97%) 
Stomatitis * 1  4/61 (6.56%)  8/62 (12.90%) 
Abdominal pain upper * 1  7/61 (11.48%)  4/62 (6.45%) 
Ascites * 1  5/61 (8.20%)  3/62 (4.84%) 
Abdominal discomfort * 1  2/61 (3.28%)  5/62 (8.06%) 
Haematochezia * 1  4/61 (6.56%)  2/62 (3.23%) 
General disorders     
Fatigue * 1  21/61 (34.43%)  33/62 (53.23%) 
Odema peripheral * 1  13/61 (21.31%)  14/62 (22.58%) 
Pyrexia * 1  7/61 (11.48%)  4/62 (6.45%) 
Asthenia * 1  8/61 (13.11%)  2/62 (3.23%) 
Pain * 1  5/61 (8.20%)  3/62 (4.84%) 
Chills * 1  4/61 (6.56%)  3/62 (4.84%) 
Early satiety * 1  2/61 (3.28%)  4/62 (6.45%) 
Oedema * 1  4/61 (6.56%)  1/62 (1.61%) 
Mucosal inflammation * 1  4/61 (6.56%)  0/62 (0.00%) 
Infections and infestations     
Urinary tract infection * 1  6/61 (9.84%)  8/62 (12.90%) 
Sinusitis * 1  4/61 (6.56%)  4/62 (6.45%) 
Upper respiratory tract infection * 1  4/61 (6.56%)  3/62 (4.84%) 
Rhinitis * 1  5/61 (8.20%)  1/62 (1.61%) 
Investigations     
Ejection fraction decreased * 1  11/61 (18.03%)  13/62 (20.97%) 
Weight decreased * 1  10/61 (16.39%)  9/62 (14.52%) 
Haemoglobin decreased * 1  6/61 (9.84%)  4/62 (6.45%) 
Metabolism and nutrition disorders     
Anorexia * 1  15/61 (24.59%)  12/62 (19.35%) 
Dehydration * 1  12/61 (19.67%)  7/62 (11.29%) 
Hypokalaemia * 1  6/61 (9.84%)  9/62 (14.52%) 
Hypoalbuminaemia * 1  5/61 (8.20%)  5/62 (8.06%) 
Decreased appetite * 1  5/61 (8.20%)  3/62 (4.84%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  8/61 (13.11%)  4/62 (6.45%) 
Arthralgia * 1  3/61 (4.92%)  7/62 (11.29%) 
Muscle spasms * 1  0/61 (0.00%)  9/62 (14.52%) 
Myalgia * 1  4/61 (6.56%)  2/62 (3.23%) 
Nervous system disorders     
Headache * 1  10/61 (16.39%)  6/62 (9.68%) 
Dizziness * 1  7/61 (11.48%)  6/62 (9.68%) 
Dysgeusia * 1  4/61 (6.56%)  2/62 (3.23%) 
Paraesthesia * 1  4/61 (6.56%)  2/62 (3.23%) 
Hypoaesthesia * 1  0/61 (0.00%)  4/62 (6.45%) 
Psychiatric disorders     
Insomnia * 1  10/61 (16.39%)  5/62 (8.06%) 
Anxiety * 1  6/61 (9.84%)  5/62 (8.06%) 
Depression * 1  6/61 (9.84%)  2/62 (3.23%) 
Renal and urinary disorders     
Dysuria * 1  7/61 (11.48%)  6/62 (9.68%) 
Haematuria * 1  5/61 (8.20%)  2/62 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  9/61 (14.75%)  11/62 (17.74%) 
Dyspnoea * 1  10/61 (16.39%)  10/62 (16.13%) 
Pharyngolaryngeal pain * 1  3/61 (4.92%)  5/62 (8.06%) 
Pleural effusion * 1  6/61 (9.84%)  2/62 (3.23%) 
Epistaxis * 1  3/61 (4.92%)  4/62 (6.45%) 
Nasal congestion * 1  4/61 (6.56%)  1/62 (1.61%) 
Skin and subcutaneous tissue disorders     
Rash * 1  14/61 (22.95%)  16/62 (25.81%) 
Pruritis * 1  8/61 (13.11%)  7/62 (11.29%) 
Dry skin * 1  5/61 (8.20%)  7/62 (11.29%) 
Erythema * 1  4/61 (6.56%)  6/62 (9.68%) 
Rash erythematous * 1  2/61 (3.28%)  4/62 (6.45%) 
Nail disorder * 1  4/61 (6.56%)  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
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
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00058552     History of Changes
Obsolete Identifiers: NCT00070408
Other Study ID Numbers: TOC2689g
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: March 8, 2017