Clinical Trial: Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase II Single-arm Study of AMG 386 in Combination With Docetaxel for Advanced Urothelial Carcinoma After Failure of a Platinum-containing Regimen

Brief Summary:

This study plans to learn more about the combination of AMG 386 and docetaxel for the treatment of advanced urothelial cancer. Subjects are being asked to be in this research study because they have advanced urothelial cancer which has progressed after treatment with a platinum-based therapy.

The hypothesis is that AMG 386 will increase the historical response rate of docetaxel as a single agent.


Detailed Summary: AMG 386 is a medication made to stop the growth of blood vessels in cancer tissues. Cancer relies on new blood vessels to bring it oxygen and nutrients to grow. Docetaxel is currently approved by the FDA for advanced urothelial, hormone-refractory prostate, breast, non-small cell lung, gastric, and squamous cell carcinoma of the head and neck.
Sponsor: University of Colorado, Denver

Current Primary Outcome: Response rate [ Time Frame: Up to 21 days ]

Determine the objective response rate (by RECIST 1.1 criteria) for the combination of AMG 386 (Trebananib) with docetaxel for the treatment of advanced or metastatic urothelial carcinoma, after failure of a platinum-containing regimen


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall survival [ Time Frame: Up to 24 months ]

Determine the overall survival for the combination of AMG 386 with docetaxel in advanced or metastatic urothelial carcinoma


Original Secondary Outcome: Same as current

Information By: University of Colorado, Denver

Dates:
Date Received: July 16, 2013
Date Started: February 2014
Date Completion:
Last Updated: April 25, 2014
Last Verified: April 2014