Finding studies
Finding studies
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Lead
Ohio State University Comprehensive Cancer Center
With
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RPTD) of combination mirvetuximab soravtansine and rucaparib camsylate (rucaparib) in patients with recurrent endometrial, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of combination mirvetuximab soravtansine and rucaparib in study patients. II. To explore the objective antitumor activity (complete and partial response) of combination mirvetuximab soravtansine and rucaparib as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in the study population. III. To measure the progression free survival. IV. To evaluate the pharmacokinetics of mirvetuximab soravtansine and rucaparib in combination. EXPLORATORY OBJECTIVES: I. Explore additional biomarkers of response. II. Explore mutation characteristics and frequency with treatment response. III. Evaluate if companion diagnostics can be optimized by combining loss of heterozygosity (LOH) score and level of folate receptor a (FR-alpha) expression, and possible additional predictors of response. IV. Explore mechanisms of secondary resistance to treatment. OUTLINE: This is a dose escalation study. Participants receive mirvetuximab soravtansine intravenously (IV) on day 1 and rucaparib orally (PO) twice daily (BID) on days 1 through 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days and then every 3 months for up to a year.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
