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

Phase 1

Completed

• Conditions: Relapsed Epithelial Ovarian Cancer; Relapsed Fallopian Tube Cancer; Relapsed Primary Peritoneal Cancer
• Interventions: Drug: Birinapant; Drug: Conatumumab

• Registration Number: NCT01940172
• Lead Sponsor: TetraLogic Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-12
• Study Start: 2013-11
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Birinapant with Conatumumab	Birinapant	-
Birinapant with Conatumumab	Conatumumab	-

Primary Outcome Measures

Name	Time	Method
Determination of Maximum Tolerated Dose (MTD)	28 Days

Secondary Outcome Measures

Name	Time	Method
Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).	Up to 4 months

Trial Locations

Locations (3)

TetraLogic research site; 🇺🇸 Fresno, California, United States

TetraLogic Research Site; 🇺🇸 Nashville, Tennessee, United States

TetraLogic Research Facility; 🇺🇸 Dallas, Texas, United States