Cancer Clinical Trial
Official title:
A Phase 1b Study of AMG 386 in Combination With Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects With Advanced Recurrent Epithelial Ovarian Cancer
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.
The purpose of this study is to evaluate the effectiveness and safety of AMG 386 when used with pegylated liposomal doxorubicin or topotecan in subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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