Randomized Phase 2 Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study Status
Open to Enrollment
Study Description
The purpose of this research study is to find out if the experimental drug MLN8237, given in combination with weekly paclitaxel, can provide benefit to patients with ovarian cancer.
MLN8237 is a tablet given orally. It has been developed to interfere with cell division, which is required for cancer to grow. MLN8237 has been shown in laboratory studies to have anti-cancer activity. When given in combination with drugs called “taxanes,” like paclitaxel, MLN8237 may increase the anti-cancer activity of the taxane drugs.
Study participants will be randomly assigned to one of two study groups:
- Group 1, Weekly Paclitaxel Plus MLN8237 Treatment Cycle: 2 doses of MLN8237 per day for 3 consecutive days followed by a 4-day rest period (3 days on/4 days off). This dosing schedule will be repeated weekly for 3 weeks. At the same time, you will be required to come into the clinic weekly to receive paclitaxel for three consecutive weeks
- Group 2, Weekly Paclitaxel Treatment Cycle: weekly paclitaxel for three consecutive weeks
The number of treatment cycles you receive and therefore the time that you participate in the study depends on the severity of any potential side effects you may experience and the extent to which your cancer remains under control. You may be treated for up to 24 months in this study, although additional months of treatment may be administered if there is evidence of disease control and you are tolerating the treatment. You may also be treated after the study with paclitaxel or other agents, if you and your doctors feel such treatment would be in your best interest.
Disease Status and/or Stage
Previously Treated, Metastatic Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Sponsor
Millennium
Key Eligibility
- Women age 18 and older
- Previously treated, metastatic ovarian, fallopian tube or primary peritoneal cancer
- Previous treatment must have included a platinum and a taxane
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Dr. Gupta
- (212) 746-3307
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
