Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT03552471|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|BRCA1 Gene Mutation BRCA2 Gene Mutation Folate Receptor Alpha Positive Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Uterine Corpus Carcinoma Recurrent Uterine Serous Carcinoma Recurrent Uterine Carcinosarcoma Platinum Resistant Ovarian Cancer||Other: Laboratory Biomarker Analysis Biological: Mirvetuximab Soravtansine Other: Pharmacokinetic Study Drug: Rucaparib Camsylate||Phase 1|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Mirvetuximab Soravtansine (IMGN853) and Rucaparib for Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||August 29, 2021|
|Estimated Study Completion Date :||August 29, 2021|
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.
Other: Laboratory Biomarker Analysis
Biological: Mirvetuximab Soravtansine
Other: Pharmacokinetic Study
Drug: Rucaparib Camsylate
- 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) ]based on DLT and toxicity
- Incidence of adverse effects graded according to CTCAE v. 4.0 [ Time Frame: while on study drug and up to 30 days after (through study treatment completion, an average of 1 year) ]Will be evaluated descriptively using frequencies and percentages
- Objective anti-tumor activity (complete and partial response) of mirvetuximab soravtansine and rucaparib in combination [ Time Frame: Up to 1 year after completion of study treatment ]Response rate determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Progression-free survival [ Time Frame: From start of treatment up to 1 year after completion of study treatment ]Progression-free survival determined by Kaplan-Meier curves.
- Pharmacokinetics of mirvetuximab soravtansine and rucaparib in combination Cmax trough concentrations [ Time Frame: predose and post dose at selected times ]Pharmacokinetics determined by analysis of collected blood samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552471
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Floor Backes, MD 614-293-3873|
|Principal Investigator: Floor Backes|
|Principal Investigator:||Floor Backes, MD||Ohio State University Comprehensive Cancer Center|