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

NCT01940172 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-01-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • TetraLogic Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940172 on ClinicalTrials.gov