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Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer

This study has been terminated.
(Accrual was terminated for lack of a clinical benefit.)
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: April 24, 2017
Last verified: April 2017
Results First Received: January 21, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      9  81.8% 
>=65 years      2  18.2% 
Age 
[Units: Years]
Median (Standard Deviation)
 58.87  (6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      10  90.9% 
Unknown or Not Reported      1   9.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   9.1% 
White      9  81.8% 
More than one race      0   0.0% 
Unknown or Not Reported      1   9.1% 
Region of Enrollment 
[Units: Participants]
 
United States   11 
Eastern Cooperative Oncology Group (ECOG) [1] 
[Units: Participants]
Count of Participants
 
    0   0.0% 
    10  90.9% 
    1   9.1% 
[1] ECOG: 0 (Normal activity. Fully active, able to carry on all pre-disease performance without restriction.), 1 (Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work), and 2 (In bed <50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hour.).
Histologic subtype, No. 
[Units: Participants]
Count of Participants
 
Serous      6  54.5% 
Endometrioid      1   9.1% 
Clear cell      1   9.1% 
Classified      3  27.3% 
No. of Prior Therapies 
[Units: Participants]
Count of Participants
 
≤3      1   9.1% 
4-6      6  54.5% 
≥7      4  36.4% 
Type of Prior Therapy, No. 
[Units: Participants]
 
Chemotherapy   11 
Biologic   6 
Hormonal   5 
Vaccine   1 


  Outcome Measures
  Show All Outcome Measures

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 ]

3.  Secondary:   Mean Plasma Concentration-Time Curve of Birinapant   [ Time Frame: 30, 60, 120, 180 minutes after administration of first dose of Birinapant ]

4.  Secondary:   Birinapant Concentration in Tumor Tissue   [ Time Frame: Prior to treatment and 12 to 22 hours following Cycle 2 Day 15 ]

5.  Secondary:   Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Tumor Tissue   [ Time Frame: 0-24hr ]

6.  Secondary:   Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Plasma   [ Time Frame: 0-24hr ]

7.  Secondary:   Ratio of Phosphorylated NF-kappaB-p65 Protein to Total NF-kappaBp65 Protein in Tumor Biopsy Samples   [ Time Frame: 0-6 weeks ]

8.  Secondary:   Coexpression of Cleaved Caspase 3 and Gamma-H2AX in Fixed Specimens   [ Time Frame: Pre treatment and post treatment of Birinapant, approximately 0-6 weeks ]

9.  Secondary:   Total Clearance of Birinapant After Administration   [ Time Frame: 0-24hr ]


  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: April 24, 2017