Phase 2 AMG 386 in Comb. Paclitaxel for Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer

Summary

This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Primary Outcome Measure: • Progression free survival (PFS) Secondary Outcome Measures: * Object Response Rate (ORR), duration of response (DOR). CA-125 response rate * Safety and Tolerability * Change and duration of change on blood levels of CA-125

Timeline

Start

2007-07-05

Primary completion

2009-08-11

Completion

2019-12-09

Publications

• Background Karlan BY, Oza AM, Richardson GE, Provencher DM, Hansen VL, Buck M, Chambers SK, Ghatage P, Pippitt CH Jr, Brown JV 3rd, Covens A, Nagarkar RV, Davy M, Leath CA 3rd, Nguyen H, Stepan DE, Weinreich DM, Tassoudji M, Sun YN, Vergote IB. Randomized, double-blind, placebo-controlled phase II study of AMG 386 combined with weekly paclitaxel in patients with recurrent ovarian cancer. J Clin Oncol. 2012 Feb 1;30(4):362-71. doi: 10.1200/JCO.2010.34.3178. Epub 2011 Dec 19.
• Background Lu JF, Rasmussen E, Karlan BY, Vergote IB, Navale L, Kuchimanchi M, Melara R, Stepan DE, Weinreich DM, Sun YN. Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection. Cancer Chemother Pharmacol. 2012 May;69(5):1135-44. doi: 10.1007/s00280-011-1787-5. Epub 2012 Jan 1.
• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Drugs

Indications