Phase 2 Trial of NOV-002 With Carboplatin in Women With Recurrent and Platinum Resistant Tumors of Mullerian Origin
The purpose of this research study is to learn if adding NOV-002 to the chemotherapy drug
carboplatin works in treating ovarian cancer. Platinum containing drugs such as carboplatin
are the standard treatment for ovarian cancer, and are effective for many women. However, in
many women the cancer eventually stops responding to the chemotherapy (becomes resistant).
The active part of NOV-002 is a substance made by the body that is involved in many chemical
reactions in cells. NOV-002 does not directly kill cancer cells, but previous research has
shown that it may make cancer cells more likely to be killed by chemotherapy drugs.
Specifically, it may help platinum chemotherapy kill cancer that has become resistant to
platinum chemotherapy. Previous trials have also shown that patients receiving NOV-002 in
addition to carboplatin may have tolerated chemotherapy better than those who received
chemotherapy alone. NOV-002 has been used in other research studies on various types of
cancer. It is approved for use in Russia. It is not approved by the US Food and Drug
Administration (FDA) for use outside of research studies.
In this research study, the investigators are looking to see if adding NOV-002 to the
chemotherapy drug carboplatin works in treating ovarian cancer in women whose cancer has
stopped responding to carboplatin chemotherapy alone.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response, evaluated every other 28 day cycle of carboplatin, which is about every eight weeks
Carolyn Kransner, MD
Massachusetts General Hospital
United States: Institutional Review Board
NOV002- IS21 -OC
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer/Partners Cancer Care||Boston, Massachusetts 02115|