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

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00058552
First received: April 8, 2003
Last updated: June 2, 2015
Last verified: June 2015
Results First Received: June 2, 2015  
Study Type: Interventional
Study Design: Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: Pertuzumab (rhuMAb 2C4)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pertuzumab 420 mg 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.
Pertuzumab 1050 mg 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.

Participant Flow:   Overall Study
    Pertuzumab 420 mg     Pertuzumab 1050 mg  
STARTED     65     64  
COMPLETED     0     2  
NOT COMPLETED     65     62  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All the participants who received at least 1 dose of study drug were included in the analysis.

Reporting Groups
  Description
Pertuzumab 420 mg 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.
Pertuzumab 1050 mg 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 Total of all reporting groups

Baseline Measures
    Pertuzumab 420 mg     Pertuzumab 1050 mg     Total  
Number of Participants  
[units: participants]
  61     62     123  
Age  
[units: years]
Mean (Standard Deviation)
  58.1  (9.9)     56.5  (11.2)     57.3  (10.5)  
Gender  
[units: participants]
     
Female     61     62     123  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   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   [ 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) ]

2.  Secondary:   Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])   [ 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) ]

3.  Secondary:   Median Time of PFS   [ 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) ]

4.  Secondary:   Duration of Response   [ 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) ]

5.  Secondary:   Percentage of Participants Who Died   [ 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) ]

6.  Secondary:   Overall Survival   [ 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) ]

7.  Secondary:   Kaplan Meier Estimate of Percentage of Participants Who Were Free of Disease Progression at 3, 6, and 12 Months   [ Time Frame: 3, 6, and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



ClinicalTrials.gov Identifier: NCT00058552     History of Changes
Obsolete Identifiers: NCT00070408
Other Study ID Numbers: TOC2689g
Study First Received: April 8, 2003
Results First Received: June 2, 2015
Last Updated: June 2, 2015
Health Authority: United States: Food and Drug Administration