NCT04493619

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

A Multicenter, 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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Opna Bio LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Neoplasms
• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	PLX2853	PLX2853 tablets
DRUG	Carboplatin	Carboplatin IV injection, 5 mg•min/mL

Timeline

• Start date: 2020-08-11
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2020-07-30
• Last updated: 2024-11-04
• Results posted: 2024-11-04

Locations

9 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study