Study Complete
Sponsor ID
20070182

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

Sponsor ID
20070182
Clinicaltrials.gov ID
NCT00770536
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 386
Type
Interventional
Masking
None (Open Label)
Enrollment
103
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicity in subjects treated with AMG 386 + pegylated liposomal doxorubicin (cohort A) and with AMG 386 + topotecan

Timeframe: first 4 weeks of treatment

Secondary Outcome Measures

To evaluate the treatment effect as measured by: objective response rate (ORR), duration of response (DOR), PFS, change in tumor burden, CA 125 Response and Progression by GCIG and CA-125 duration of response

Timeframe: Treatment and follow-up phase of study

To evaluate the incidence of adverse events and clinical laboratory abnormalities not defined as DLTs.

Timeframe: first 4 weeks of treatment

To determine the pharmacokinetics of pegylated liposomal doxorubicin (and its metabolite, doxorubicinol), topotecan and AMG 386 (Cmax, AUC, and Cmin for intensive assessment; Cmax and Cmin for sparse assessment).

Timeframe: Treatment and follow-up phase of study

To estimate the incidence of anti AMG 386 antibody formation.

Timeframe: Treatment and follow-up phase of study

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Tampa, FL, United States, 33612
Status
Recruiting
Location
Research Site
St. Louis Park, MN, United States, 55426
Status
Recruiting
Location
Research Site
Sacramento, CA, United States, 95817
Status
Recruiting
Location
Research Site
Bismarck, ND, United States, 58501
Status
Recruiting
Location
Research Site
Columbus, OH, United States, 43219
Status
Recruiting
Location
Research Site
Tucson, AZ, United States, 85724-5024
Status
Completed
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