Ovarian Cancer Clinical Trial

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

Summary

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

View Full Description

Full Description

This international, randomized, open-label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator's Choice of Treatments (ICT) in patients with recurrent LGSOC who have progressed on a prior platinum-based therapy. Avutometinib and defactinib are both a type of drug called a kinase inhibitor. Kinase inhibitors block cancer cell growth. The study will compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib versus ICT. The study will also evaluate the effect of the combination on safety, overall survival, other efficacy endpoints, and health-related quality of life and disease related symptoms. The study is being conducted by gynecological cancer specialists. Patients who are eligible and agree to participate in this study will be treated with either a combination of avutometinib with defactinib, or with one of five standard of care NCCN and ESMO treatment recommendations for recurrent LGSOC, and then with subsequent follow up appointments. Patients who originally received one of the standard of care treatments who are determined to have progressive disease may be eligible to crossover to receive the investigational combination avutometinib plus defactinib.Avutometinib and defactinib are investigational drugs that have not been approved by the U.S. Food and Drug Administration (FDA)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients may be eligible for inclusion in the study if they meet the following criteria:

Histologically proven LGSOC (ovarian, fallopian, peritoneal)
Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
Measurable disease according to RECIST v1.1.
An Eastern Cooperative Group (ECOG) performance status ≤ 1.
Adequate organ function
Adequate recovery from toxicities related to prior treatments.
For patients with reproductive potential, Agreement to use highly effective method of contraceptive.
Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
Co-existing high-grade ovarian cancer or another histology.
Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
History of prior malignancy with recurrence <3 years from the time of enrollment.
Major surgery within 4 weeks.
Symptomatic brain metastases or spinal cord compression.
An active skin disorder that has required systemic therapy within one year of signing informed consent.
History of medically significant rhabdomyolysis.
For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor.
Symptomatic bowel obstruction within 3 months.
Concurrent ocular disorders.
Concurrent heart disease or severe obstructive pulmonary disease.
Subjects with the inability to swallow oral medications.
Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

270

Study ID:

NCT06072781

Recruitment Status:

Recruiting

Sponsor:

Verastem, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 20 Locations for this study

See Locations Near You

HonorHealth
Phoenix Arizona, 85016, United States More Info
Kelly Fillbrant
Contact
[email protected]
Lyndsay Willmott, MD
Principal Investigator
Yale University
New Haven Connecticut, 06520, United States More Info
Lisa Baker
Contact
[email protected]
Alessandro Santin, MD
Principal Investigator
AdventHealth
Orlando Florida, 32804, United States More Info
Karla Hernandez-Cruz
Contact
[email protected]
Robert Holloway, MD
Principal Investigator
NorthShore University HealthSystem
Evanston Illinois, 60201, United States More Info
Michele Britto
Contact
[email protected]
Mary Tilley Jenkins-Vogel, MD
Principal Investigator
Karmanos Cancer Center
Detroit Michigan, 48201, United States More Info
Elizabeth Linnik
Contact
[email protected]
Robert Morris, MD
Principal Investigator
Minnesota Oncology Hematology
Minneapolis Minnesota, 55404, United States More Info
Kayla McDonald
Contact
[email protected]
Lauren Bollinger, MD
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Linda Odibo
Contact
[email protected]
Premal Thaker, MD
Principal Investigator
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Jacqueline Ludwig
Contact
[email protected]
Peter Rose, MD
Principal Investigator
University of Oklahoma Medical Center
Oklahoma City Oklahoma, 73104, United States More Info
Stephanie Chaney
Contact
[email protected]
Christina Washington, MD
Principal Investigator
Willamette Valley Cancer Institute
Eugene Oregon, 97401, United States More Info
Jeanne Scahffer
Contact
[email protected]
Charles Anderson, MD
Principal Investigator
Northwest Cancer Specialists
Portland Oregon, 97227, United States More Info
Jennifer Thompson
Contact
[email protected]
Erin Salinas, MD
Principal Investigator
Allegheny Health Network
Pittsburgh Pennsylvania, 15224, United States More Info
Siobhan Guyach
Contact
[email protected]
Thomas Krivak, MD
Principal Investigator
Texas Oncology Central
Austin Texas, 78731, United States More Info
Michelle Owens
Contact
[email protected]
Lynn Knowles, MD
Principal Investigator
Texas Oncology
San Antonio Texas, 78229, United States More Info
Shannon Syring
Contact
[email protected]
Antonio Santillan Gomez, MD
Principal Investigator
Texas Oncology
The Woodlands Texas, 77380, United States More Info
Christina Genthon
Contact
[email protected]
Sandra Thornton
Contact
[email protected]
Christine Lee, MD
Principal Investigator
Texas Oncology
Tyler Texas, 75702, United States More Info
Shelly Maxfield
Contact
[email protected]
Anna M Priebe, MD
Principal Investigator
University of Virginia Health System
Charlottesville Virginia, 22908, United States More Info
Magnifique Irakoze
Contact
[email protected]
Kari Ring, MD
Principal Investigator
Virginia Cancer Specialists, PC
Gainesville Virginia, 20155, United States More Info
Monica Cochrane
Contact
[email protected]
Robert Marsh, MD
Principal Investigator
Icon Cancer Centre Wesley
Auchenflower Queensland, 4066, Australia More Info
Amy Morrow
Contact
[email protected]
Jeffrey Goh, MD
Principal Investigator
Cancer Research South Australia
Adelaide South Australia, 5000, Australia More Info
Vineet Kwatra, MD
Contact
[email protected]
Meena Okera, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

270

Study ID:

NCT06072781

Recruitment Status:

Recruiting

Sponsor:


Verastem, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.