The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in Advanced Gynecological Malignancies with a Known ARID1A Mutation and PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
PLX2853 tablets
Carboplatin IV injection, 5 mg•min/mL
The University of Chicago Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Phase 2a (PLX2853 Monotherapy): Number of Participants With Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: From 8 weeks of treatment for only PLX2853 (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.
Phase 1b (PLX2853 + Carboplatin Combination): Establish the Number of Participants Reaching MTD/RP2D for the Combination of PLX2853 and Carboplatin
MTD is defined as the maximum tolerated dose, which is determined from dose-limiting toxicity. If DLTs are observed in 2 or more of 6 subjects (or ≥33% of the cohort) at a dose level, the dose at which this occurs will be considered intolerable and the MTD will have been exceeded. The MTD is the dose below the intolerable dose. RP2D is the recommended Phase 2 dose, which was determined to be 80 mg
Time frame: From time of first dose of PLX2853 and carboplatin until 30 days of end of treatment an average of 6 months.
Phase 2a (PLX2853 + Carboplatin Combination): Number of Participants Reaching ORR as Measured by RECIST v1.1
Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: From 8 weeks of treatment with PLX2853 and Carboplatin (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.
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University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Tennessee Oncology / Sarah Cannon
Nashville, Tennessee, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
University of Washington / Seattle Cancer Care Alliance
Seattle, Washington, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada