A Phase 1b/2a study for patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer or those with advanced gynecological malignancies with a known ARID1A mutation

UVA Tracking #
HSR200181
Principal Investigator
Linda R Duska
Contact
Anne Gabel
Contact Email
Contact Phone
434.982.6657
Official Trial Title
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
Study Description

The UVA Cancer Center has a clinical trial for women ages 18 and over who have epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer) that is no longer responding to platinum-based treatments OR those who have advanced gynecological cancer with a change in the ARID1A gene.

The purpose of the Phase 1 portion of the study is to test the safety and effectiveness of the BRD4 inhibitor investigational drug, PLX2853, in combination with chemotherapy drug, Carboplatin, and to try to determine the most appropriate dose of it for future studies.

The Phase 2A portion will focus on how effective PLX2853 is at treating subjects with advanced gynecological cancers with a change in their ARID1A gene, a mutation that is associated with cancer.

The overall trial does not have a set duration, study treatment will continue for as long are your study doctor thinks the medicine is helping you or another reason for discontinuation has been presented. After you have stopped taking the study drug, your study doctor will continue to watch you for side effects and follow your condition. Likewise, if you discontinue study treatment you will be asked to return to the study center for a 30-day follow-up visit.

If eligible and you choose to participate, research-specific procedures and the study drug (PLX2853) will be provided at no cost to you. The costs of standard tests, procedures, and treatment of complications will be paid by your insurer in the same way as if you were not part of this study. You may be responsible for any extra costs your insurance company does not pay.

Additional information can be found here: NCT04493619

Compensation

No Compensation