Study on Avutometinib and Defactinib for Recurrent Low-Grade Serous Ovarian Cancer

Sponsor: Verastem, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06072781

Provider View

This clinical trial is testing a new combination of drugs, Avutometinib and Defactinib, to see if they are safe and effective in treating recurrent low-grade serous ovarian cancer (LGSOC) that has returned after previous treatment.

Patient Parameters

Program Overview

The study aims to find out if the combination of Avutometinib and Defactinib can help control low-grade serous ovarian cancer (LGSOC) that has come back after treatment with platinum-based chemotherapy. These drugs are called kinase inhibitors, which work by blocking cancer cell growth. The trial will compare this new combination to other standard treatments chosen by doctors. Researchers will look at how long patients live without the cancer getting worse, overall survival, safety, and quality of life. Patients who join the study will receive either the new drug combination or one of the standard treatments. If the cancer continues to grow on the standard treatment, patients may switch to the new combination. Avutometinib and Defactinib are investigational drugs, meaning they are not yet approved by the FDA.

Description

This international study involves patients with recurrent low-grade serous ovarian cancer (LGSOC) who have already been treated with platinum-based chemotherapy. The trial is open-label, meaning both the doctors and patients know which treatment is being given. Participants will be randomly assigned to receive either the investigational combination of Avutometinib and Defactinib or one of five standard treatments recommended for LGSOC. The study will measure how long patients live without their cancer getting worse, as well as overall survival, safety, and quality of life. If patients on standard treatment experience cancer progression, they may switch to the investigational combination. The study is conducted by specialists in gynecological cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of low-grade serous ovarian cancer (LGSOC) affecting the ovaries, fallopian tubes, or peritoneum.
  • The cancer must have returned or progressed after at least one previous treatment for metastatic disease.
  • Have measurable cancer according to specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function and recovery from previous treatment side effects.
  • Agree to use effective contraception if of reproductive potential.
  • Be willing to attend scheduled visits and follow the treatment plan and study procedures.

Exclusion Criteria

  • Have received any anti-cancer treatment within four weeks before starting the study.
  • Have high-grade ovarian cancer or another type of cancer.
  • Have previously been treated with Avutometinib, Defactinib, or similar drugs.
  • Have had another cancer that returned within three years before joining the study.
  • Have had major surgery within four weeks before starting the study.
  • Have brain metastases or spinal cord compression causing symptoms.
  • Have an active skin disorder requiring treatment within the past year.
  • Have a history of severe muscle breakdown (rhabdomyolysis).
  • Have had severe side effects from previous MEK inhibitor treatment.
  • Have had a bowel obstruction within the past three months.
  • Have eye disorders or serious heart or lung disease.
  • Be unable to swallow pills.
  • Have an active, uncontrolled infection requiring treatment.

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