PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer

Official Title

A Multicentre, Open-Label, Parallel, Phase 2a Study of PLX2853 Monotherapy in Advanced Gynecological Malignancies With a Known ARID1A Mutation and Phase 1b/2a Study of PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer

Summary:

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.

Trial Description

Primary Outcome:

• Phase 2a (PLX2853 monotherapy): overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
• Phase 1b (PLX2853 + carboplatin combination): establish the MTD/RP2D for the combination of PLX2853 and carboplatin
• Phase 2a (PLX2853 + carboplatin combination): ORR as measured by RECIST v1.1

• Incidence of TEAEs that are related to treatment (both arms)
• Incidence of TEAEs that result in dose interruption, reduction or discontinuation (both arms)
• Incidence of treatment-emergent ECG abnormalities (both arms)
• Incidence of treatment-emergent laboratory abnormalities (both arms)
• Duration Of Response (DOR) (both arms)
• Disease control rate (DCR) (both arms)
• Progression-free survival (PFS) (both arms)
• Overall survival (OS) (both arms)
• PLX2853 PK parameter AUC0-last (both arms)
• PLX2853 PK parameter AUC0-24 (both arms)
• PLX2853 PK parameter AUC0-∞ (both arms)
• PLX2853 PK parameter Cmax (both arms)
• PLX2853 PK parameter Tmax (both arms)
• PLX2853 PK parameter T1/2 (both arms)
• PLX2853 PK parameter accumulation ratio at steady state (both arms)

View this trial on ClinicalTrials.gov