A Phase IB/IIA Study of PLX2853 Alone for Gynecological Cancers and PLX2853 with Carboplatin for Persistent Ovarian Cancer

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Full 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

Purpose

The purpose of this study is to assess the safety and effectiveness of the drug PLX2853 alone in women with gynecologic cancers and with carboplatin chemotherapy in women with persistent ovarian cancer. PLX2853 works by slowing down activities within cells that promote tumor growth. It may help stabilize or reduce the growth of tumor cells.

PLX2853 will be given alone in women with metastatic gynecologic cancers that contain a mutation in a gene called ARID1A. PLX2853 has been shown to be effective against cancer cells containing this mutation.

PLX2853 will be given in combination with carboplatin in women with ovarian cancer that persists despite platinum-containing therapy. PLX2853 is taken orally (by mouth) and carboplatin is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have either a metastatic gynecologic cancer (cervical, vaginal, vulvar, uterine, ovarian, fallopian tube, or primary peritoneal cancer) that contains an ARID1A mutation OR ovarian cancer that continues to grow despite platinum-containing therapy.
  • At least 2 weeks must pass since the completion of prior treatment (3 weeks for immunotherapies) and receipt of the study medication.
  • Patients must be physically well enough, meaning that they are fully ambulatory, capable of all self-care, and able to perform mild physical activity. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dmitriy Zamarin at 646-888-4882.

Protocol

20-360

Phase

I/II

Investigator

Co-Investigators