Study on Avutometinib Alone or with Defactinib for Recurrent Low-Grade Serous Ovarian Cancer with or without KRAS Mutation
Sponsor: Verastem, Inc.
ClinicalTrials ID:NCT04625270
This clinical trial is testing the safety and effectiveness of the drug avutometinib, both on its own and combined with defactinib, in patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC).
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate how safe and effective the drug avutometinib is when used alone or together with another drug, defactinib, in treating patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC).
Description
This study involves multiple centers and is in Phase 2, meaning it is focused on assessing the safety, tolerability, and initial effectiveness of the treatments. Participants will be randomly assigned to receive either avutometinib alone or in combination with defactinib. The study is open-label, so both the participants and the researchers know which treatment is being administered. The goal is to see how well these treatments work in patients whose cancer has returned after previous treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Low-Grade Serous Ovarian Cancer (LGSOC) in the ovaries or peritoneum.
- Cancer has 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 good organ function as determined by medical tests.
- Have recovered from any side effects of previous treatments.
- Agree to use effective contraception if necessary.
Exclusion Criteria
- Have received any anti-cancer treatment within 4 weeks before starting the study.
- Have another type of high-grade ovarian cancer or different cancer type.
- Have had another cancer that returned within 3 years before joining the study.
- Have had major surgery within 4 weeks before starting the study.
- Have brain cancer that causes symptoms and requires treatment.
- Have had COVID-19 symptoms within 28 days before starting the study.
- Have had severe side effects from previous MEK inhibitor treatments.
- Have an active skin condition that needed treatment in the past year.
- Have a history of muscle breakdown (rhabdomyolysis).
- Have eye disorders or serious heart or lung diseases.
- Cannot swallow pills.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Oncology Associates PC HAL | 85258 | Scottsdale | Arizona |
| Sansum Clinic | 93105 | Santa Barbara | California |
| Yale School of Medicine | 06510 | New Haven | Connecticut |
| Advent Health | 32804 | Orlando | Florida |
| H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology | 33612 | Tampa | Florida |
| University of Chicago | 60637 | Chicago | Illinois |
| Maryland Oncology and Hematology, P.A. | 20769 | Glenn Dale | Maryland |
| Minnesota Oncology Hematology PA | 55404 | Minneapolis | Minnesota |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Comprehensive Cancer Centers of Nevada | 89128 | Las Vegas | Nevada |
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