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 — OTHER
    Correlative studies
  • Mirvetuximab Soravtansine — BIOLOGICAL
    Given IV
  • Pharmacokinetic Study — OTHER
    Correlative studies
  • Rucaparib Camsylate — DRUG
    Given 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)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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