Ovarian Cancer Clinical Trial
A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation
Summary
This study will assess the safety and efficacy of VS-6766 monotherapy and in combination with Defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Full Description
This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.
Eligibility Criteria
Inclusion Criteria:
Histologically proven LGSOC (ovarian, peritoneal)
Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
Measurable disease according to RECIST 1.1
An Eastern Cooperative Group (ECOG) performance status ≤ 1.
Adequate organ function
Adequate recovery from toxicities related to prior treatments
Agreement to use highly effective method of contraceptive, if necessary
Exclusion Criteria:
Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
Co-existing high-grade ovarian cancer or another histology
History of prior malignancy with recurrence <3 years from the time of enrollment
Major surgery within 4 weeks
Symptomatic brain metastases requiring steroids or other interventions
Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy
For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor
Active skin disorder that has required systemic therapy within the past year
History of rhabdomyolysis
Concurrent ocular disorders
Concurrent heart disease or severe obstructive pulmonary disease
Subjects with the inability to swallow oral medications
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There are 46 Locations for this study
Scottsdale Arizona, 85258, United States
Santa Barbara California, 93105, United States
New Haven Connecticut, 06510, United States
Orlando Florida, 32804, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60637, United States
Glenn Dale Maryland, 20769, United States
Minneapolis Minnesota, 55404, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89128, United States
Albuquerque New Mexico, 87131, United States
New York New York, 10065, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43212, United States
Oklahoma City Oklahoma, 73104, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97227, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78731, United States
Dallas Texas, 75231, United States
Dallas Texas, 75390, United States
Longview Texas, 75601, United States
McAllen Texas, 78503, United States
San Antonio Texas, 78240, United States
The Woodlands Texas, 77380, United States
Charlottesville Virginia, 22908, United States
Gainesville Virginia, 20155, United States
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Montréal , H2X 0, Canada
Toronto , M5G2M, Canada
Besançon , 2500, France
Lyon , 69008, France
Montpellier , 34298, France
Paris , 75248, France
Milano , 20141, Italy
Padova , 35128, Italy
Barcelona , 08035, Spain
Córdoba , 14004, Spain
Madrid , 28034, Spain
Valencia , 46010, Spain
Edinburgh , EH4 2, United Kingdom
Glasgow , G120Y, United Kingdom
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , , United Kingdom
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