Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christina Annunziata, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01681368
First received: September 5, 2012
Last updated: January 21, 2015
Last verified: January 2015
Results First Received: January 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Epithelial Ovarian Cancer
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Intervention: Drug: Birinapant (TL32711)

  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
Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca

single arm

Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle


Participant Flow:   Overall Study
    Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca  
STARTED     11  
COMPLETED     9  
NOT COMPLETED     2  
Refused further treatment                 1  
Refused further follow up                 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
Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca

single arm

Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle


Baseline Measures
    Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     2  
Age  
[units: years]
Median (Standard Deviation)
  58.87  (6)  
Gender  
[units: participants]
 
Female     11  
Male     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     10  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     9  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures
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1.  Primary:   Objective Response (Complete Response (CR) or Partial Response (PR) Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria) or Disease Stabilization for Greater Than 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 8 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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Christina Annunziata
Organization: National Cancer Institute
phone: 301-402-7189
e-mail: annunzic@mail.nih.gov


Publications:

Responsible Party: Christina Annunziata, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01681368     History of Changes
Other Study ID Numbers: 120191, 12-C-0191
Study First Received: September 5, 2012
Results First Received: January 21, 2015
Last Updated: January 21, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration