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Investigator(s):
Christina M. Annunziata, M.D., Ph.D. Principal Investigator Phone: 301-402-7189 Fax: 301-480-6255 annunzic@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov	Jessica Hearn, B.S.N., R.N. Research Nurse Phone: 301-435-4859 Jessica.Hearn@nih.gov

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Key Eligibility Criteria:

• Histologically or cytologically confirmed diagnosis of advanced metastatic or unresectable epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
• Relapsed and resistant or refractory to prior platinum-based standard of care systemic regimen
• There is no limitation on the amount of prior therapies allowed
• Measurable disease by RECIST criteria
• ECOG ≤ 2
• ≥ 18 years of age
• Adequate renal, hepatic, and bone marrow function
• Normal coagulation

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Study Outline:

• Screening physical examination and imaging studies to determine eligibility for the study
• Participants will have an IV infusion (through a vein) 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
• Cycles continue for as long as there is no progressive disease or unacceptable toxicity
• Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment
• A biopsy of a tumor site is required to be eligible for the study

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 9/17/12