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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 3
- Primary Endpoint
- Determination of Maximum Tolerated Dose (MTD)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Birinapant with Conatumumab
Intervention: Birinapant (Drug)
Birinapant with Conatumumab
Intervention: Conatumumab (Drug)
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)