drugset / Trial / NCT00770536

AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR

NCT00770536

Phase 1 Completed 103 enrolled Amgen
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and assignment to either cohort will be based on eligibility and the investigator's discretion. It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens: either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in subjects with recurrent ovarian cancer.

Timeline

Start
2009-01
Primary completion
2012-01
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Topotecan Small molecule 4 mg/m2 Intravenous
Subject Trebananib Peptide 10 mg/kg Intravenous
Subject Trebananib Peptide 15 mg/kg Intravenous