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Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer

NCT01681368 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-05-30

Study results available
· View outcomes & findings →

Summary

Background:

\- 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.

Objectives:

\- To test the effectiveness of Birinapant for ovarian, primary peritoneal, or fallopian tube cancer.

Eligibility:

\- Women at least 18 years of age who have ovarian, primary peritoneal, or fallopian tube cancer that has not responded to standard treatment.

Design:

* 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.

Conditions

  • Epithelial Ovarian Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Interventions

DRUG

Birinapant (TL32711)

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Christina M Annunziata, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-15
Primary Completion
2013-12-09
Completion
2014-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01681368 on ClinicalTrials.gov