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NCT01681368 · ClinicalTrials.gov registry record · Phase 2
Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01681368: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01681368 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681368, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Birinapant (TL32711)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-08-15 |
| Est. Completion | 2014-04-30 |
| Phase | Phase 2 |
Why NCT01681368 stopped before completion
NCT01681368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Birinapant (TL32711) is the first listed.
NCT01681368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01681368 about?
NCT01681368 is a clinical study titled "Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer". 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 tr...
What is the current status of trial NCT01681368?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2012-08-15. Estimated completion is 2014-04-30.
What interventions are being tested in trial NCT01681368?
The interventions under investigation include: Birinapant (TL32711) (DRUG).
Who is sponsoring clinical trial NCT01681368?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01681368's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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