A Study of ENMD-2076 in Ovarian Clear Cell Cancers

Official Title

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

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 tumour 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 tumours may stop growing or shrink.

Trial Description

Primary Outcome:

  • Number of patients with and without disease progression at 6 months after treatment
  • Percentage of patients with complete or partial response
Secondary Outcome:
  • Length of response in patients treated with ENMD-2076
  • Levels of certain proteins and gene expression compared to patient outcome following treatment
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, tumour tissue (archival and fresh tumour 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society