Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Study ID
- NCT03552471
- Phase
- PHASE1
- Status
- Completed
Conditions
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
- Folate Receptor Alpha Positive
- Platinum Resistant Ovarian Cancer
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Recurrent Uterine Carcinosarcoma
- Recurrent Uterine Corpus Carcinoma
- Recurrent Uterine Serous Carcinoma
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Mirvetuximab Soravtansine — BIOLOGICALGiven IV
- Pharmacokinetic Study — OTHERCorrelative studies
- Rucaparib Camsylate — DRUGGiven PO
Study Details
This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and rucaparib camsylate in treating participants with endometrial, ovarian, fallopian tube or primary peritoneal cancer that has come back. Drugs such as mirvetuximab soravtansine are antibodies linked to a toxic substance and may help find certain tumor cells and kill them without harming normal cells. Rucaparib camsylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving mirvetuximab soravtansine and rucaparib camsylate may work better in treating participants with recurrent endometrial, ovarian, fallopian tube or primary peritoneal cancer.
Key Dates
- Start date
- Jul 12, 2018
- Status verified
- Dec 2024
- Primary completion
- Jun 24, 2022
- Completion
- Dec 19, 2022
Study Design
- Enrollment
- 25 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (mirvetuximab soravtansine, rucaparib)Participants receive mirvetuximab soravtansine IV on day 1 and rucaparib PO BID on days 1 through 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Recommended phase II dose (RPTD) of mirvetuximab soravtansine and rucaparib camsylate in combination [ Time Frame: At the end of Cycle 1 (each cycle 15 days) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | - |
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