A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00739661
First received: August 21, 2008
Last updated: April 2, 2012
Last verified: April 2012
Results First Received: February 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: Vismodegib 150 mg
Drug: Placebo to vismodegib

  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
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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
Vismodegib 150 mg Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Placebo to Vismodegib Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.

Participant Flow:   Overall Study
    Vismodegib 150 mg     Placebo to Vismodegib  
STARTED     52     52  
COMPLETED     6     10  
NOT COMPLETED     46     42  
Adverse Event                 2                 0  
Physician decision to withdraw patient                 1                 0  
Patient decision to withdraw                 9                 4  
Disease progression, radiographic                 33                 37  
Reason for discontinuation not available                 1                 1  



  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.
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Reporting Groups
  Description
Vismodegib 150 mg Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Placebo to Vismodegib Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Total Total of all reporting groups

Baseline Measures
    Vismodegib 150 mg     Placebo to Vismodegib     Total  
Number of Participants  
[units: participants]
  52     52     104  
Age  
[units: years]
Mean ± Standard Deviation
  57.3  ± 10.2     58.6  ± 8.9     57.9  ± 9.6  
Gender  
[units: participants]
     
Female     52     52     104  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks ]

2.  Secondary:   Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression   [ Time Frame: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks ]

3.  Secondary:   Overall Survival   [ Time Frame: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks ]


  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: Genentech, Inc
phone: 800-821-8590


No publications provided


Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00739661     History of Changes
Other Study ID Numbers: SHH4489g
Study First Received: August 21, 2008
Results First Received: February 10, 2012
Last Updated: April 2, 2012
Health Authority: United States: Food and Drug Administration