Phase 2 Study of Avutometinib (VS-6766) and Defactinib for Gynecological Cancers

Sponsor: University of Oklahoma

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05512208

Provider View

This clinical trial is testing the safety and effectiveness of two study drugs, Avutometinib (VS-6766) and Defactinib, in treating certain types of gynecological cancers, including endometrioid, mucinous ovarian, high-grade serous ovarian, and cervical cancer.

Patient Parameters

Program Overview

The study aims to evaluate how well the combination of Avutometinib (VS-6766) and Defactinib works in treating patients with specific types of gynecological cancers. Researchers will monitor the effects of these drugs, both positive and negative, on patients. Participants will take the study drugs orally and attend regular study visits for various tests, including physical exams, tumor assessments, and blood and urine tests.

Description

This Phase 2 study is being conducted at multiple centers and involves patients taking Avutometinib (VS-6766) and Defactinib orally. The study will follow a set of procedures, including regular visits for physical exams, checking vital signs, measuring tumor size, and testing blood and urine. Additional visits may be required to monitor any side effects experienced by the patients.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with certain types of gynecological cancers that have specific genetic mutations (RAS, BRAF, NF-1, or RAS activation).
  • Cancer must have progressed or returned after at least one previous treatment for advanced disease.
  • Must have measurable disease according to specific criteria.
  • Good overall health with a performance status score of 0 or 1.
  • Adequate organ function based on specific blood tests.
  • Must not have had certain treatments or surgeries recently.
  • Women of childbearing potential and their partners must agree to use effective contraception during the study and for three months after the last dose.

Exclusion Criteria

  • Recent treatment with other anti-cancer therapies or certain drugs.
  • History of certain other cancers or medical conditions.
  • Candidates for surgery to remove tumors.
  • Recent major surgery or radiation therapy.
  • Current use of certain medications that affect the study drugs.
  • Active brain metastases requiring treatment.
  • Recent COVID-19 infection or active hepatitis B, C, or HIV.
  • Active skin disorders or eye conditions that could affect the study.
  • Heart failure or other serious heart conditions.
  • Difficulty swallowing or absorbing oral medications.
  • Allergies to ingredients in the study drugs.
  • Pregnant or breastfeeding women.
  • Any other medical condition that could increase the risk of side effects.

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