Clinical Trial: A Study of ENMD-2076 in Ovarian Clear Cell Cancers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Oral ENMD-2076 Administered to Patients With Ovarian Clear Cell Carcinomas

Brief Summary:

This is a phase 2 study to see how useful, safe, and tolerable an investigational drug called ENMD-2076 is in treating patients with ovarian clear cell carcinomas.

ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A and tyrosine kinase from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A and tyrosine kinase enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.


Detailed Summary: During the study, participants will be asked to take ENMD-2076 once a day, everyday. Every 28 days will be called a cycle. While receiving the study drug, participants will be asked to visit the clinic for tests and procedures. During Cycle 1, participants will be asked to visit the clinic about once a week and during Cycle 2 and future cycles, participants will be asked to visit the clinic on days 1 and 15. As a part of the study, tumor tissue (archival and fresh tumor biopsy) will be taken for biomarker research. When participants stop the study drug, they will be asked to have an end of study drug visit.
Sponsor: University Health Network, Toronto

Current Primary Outcome:

  • Number of patients with and without disease progression at 6 months after treatment [ Time Frame: 2 years ]
  • Percentage of patients with complete or partial response [ Time Frame: 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of response in patients treated with ENMD-2076 [ Time Frame: 2 years ]
  • Levels of certain proteins and gene expression compared to patient outcome following treatment [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: July 11, 2013
Date Started: September 2013
Date Completion: January 2018
Last Updated: August 5, 2016
Last Verified: August 2016