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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Overall survival [ Time Frame: Up to 24 months ]
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