A Phase 1b, Open-label, Non-randomized Multicenter Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer
Overview
- Phase
- Phase 1
- Intervention
- Birinapant
- Conditions
- Relapsed Epithelial Ovarian Cancer
- Sponsor
- TetraLogic Pharmaceuticals
- Enrollment
- 27
- Locations
- 3
- Primary Endpoint
- Determination of Maximum Tolerated Dose (MTD)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is a dose escalation study in female subjects with relapsed ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Approximately 30 to 40 subjects will be administered a combination of conatumumab and birinapant.
In the initial dose-escalation stage of the study, adult female subjects will receive conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to determine the MTD of birinapant when administered with a fixed dose of conatumumab.
In safety expansion stage, adult female subjects will receive conatumumab in combination with birinapant at the MTD of the combination.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Birinapant with Conatumumab
Intervention: Birinapant
Birinapant with Conatumumab
Intervention: Conatumumab
Outcomes
Primary Outcomes
Determination of Maximum Tolerated Dose (MTD)
Time Frame: 28 Days
Secondary Outcomes
- Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).(Up to 4 months)