A Study of ENMD-2076 in Ovarian Clear Cell Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01914510|
Recruitment Status : Completed
First Posted : August 2, 2013
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Clear Cell Carcinoma||Drug: ENMD-2076||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Oral ENMD-2076 Administered to Patients With Ovarian Clear Cell Carcinomas|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday.
- Six Month Progression Free Survival Rate [ Time Frame: Response will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. Progression free survival is the time from the first day of treatment to the first observation of disease progression or Death/last F/U. ]Progression Free Survival (PFS) is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause or last follow up. PFS will be censored for patients who are alive and free of progression at time of last follow-up.
- Complete or Partial Response Rate [ Time Frame: 2 years ]Percentage of patients with complete or partial response as per RECIST 1.1 criteria.
- Time to Disease Progression [ Time Frame: 2 years ]Length of time until disease progression in patients treated with ENMD-2076
- Levels of Certain Proteins and Gene Expression Compared to Patient Outcome Following Treatment [ Time Frame: 2 years ]Association of somatic mutations in PIK3CA, ARID1A and PTEN mutation status, and ARID1A and PTEN expression assessed in archival samples and tumour biopsies with tumour response and patient outcome following treatment with ENMD 2076.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914510
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|British Columbia Cancer Agency|
|Vancouver, Alberta, Canada, V5Z 4E6|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Amit Oza, M.D.||Princess Margaret Cancer Centre|