drugset / Trial / NCT01940172

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

NCT01940172

Phase 1 Completed 27 enrolled TetraLogic Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-11
Primary completion
2015-09
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Birinapant Small molecule 11 mg/m2
Subject Birinapant Small molecule 13 mg/m2
Subject Conatumumab Monoclonal antibody 10 mg/kg Intravenous