Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer
- Birinapant is an experimental cancer treatment drug. It removes certain proteins in cells, which helps to kill the cells. The drug is more likely to cause the death of cancer cells than normal cells because cancer cells have more of these proteins. Studies suggest that it can help treat ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Researchers want to see how well Birinapant works against the three types of cancer.
- To test the effectiveness of Birinapant for ovarian, primary peritoneal, or fallopian tube cancer.
- Women at least 18 years of age who have ovarian, primary peritoneal, or fallopian tube cancer that has not responded to standard treatment.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Tumor tissue samples may be collected before treatment. Imaging studies will also be performed.
- Participants will have an infusion of Birinapant once per week for 3 weeks in a row, followed by a break for a week on the fourth week. This 4-week schedule is one cycle of treatment.
- Treatment will be monitored with frequent blood tests and imaging studies.
- Another optional tumor biopsy will be collected 6 weeks after the start of treatment.
- Treatment will continue as long as the cancer does not grow and the side effects are not severe.
Epithelial Ovarian Cancer
Fallopian Tube Neoplasms
Drug: Birinapant (TL32711)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Open Label Non-Randomized Single Agent Study of the SMAC (Second Mitochondrial-Derived Activator of Caspases)-Mimetic Birinapant (TL32711; NSC 756502) in Relapsed Platinum Resistant or Refractory Epithelial Ovarian Cancer, Primary Peritoneal|
- 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 ] [ Designated as safety issue: No ]Per the RECIST criteria, CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Number of Participants With Adverse Events [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
|Study Start Date:||August 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca
Drug: Birinapant (TL32711)
47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681368
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Christina M Annunziata, M.D.||National Cancer Institute (NCI)|