A Phase II Study of VS-6766 Alone or with Defactinib in Women with Metastatic Low-Grade Serous Ovarian Cancer that Came Back

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Full Title

A Phase 2 Study of Avutometinib (VS-6766, a Dual RAF/MEK Inhibitor) Alone and In Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 201)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drugs VS-6766 and defactinib in women with advanced low-grade serous ovarian cancer that came back after prior treatment. Both drugs belong to a class of drugs called “kinase inhibitors.” These drugs target enzymes found on the surface of cells; cancer cells need these enzymes to survive and grow. When they are blocked, the cancer may stop growing or grow more slowly, and cancer cells may shrink.

Patients will be randomly assigned to receive VS-6766 alone or VS-6766 plus defactinib. Both drugs are taken orally (by mouth).

Who Can Join

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

  • Patients must have metastatic low-grade serous ovarian cancer that came back after at least one prior regimen of platinum-based chemotherapy for advanced disease.
  • At least 4 weeks must pass since the completion of prior treatment and receipt of the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. 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. Rachel Grisham at 646-888-4653.

Protocol

21-050

Phase

Phase II (phase 2)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04625270