NCT01940172

Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: TetraLogic Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Epithelial Ovarian Cancer
• Relapsed Primary Peritoneal Cancer
• Relapsed Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Birinapant	Dose Escalation: Dose Level (1) - 13 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (2) - 13 mg/m2 (twice weekly for 4 weeks );
DRUG	Conatumumab	10 mg/kg IV on Day 1 and 15 of each cycle

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2013-09-12
• Last updated: 2016-01-14

Locations

9 sites across 1 country: United States