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 More Info
Principal Investigator
Santa Barbara California, 93105, United States More Info
Principal Investigator
New Haven Connecticut, 06510, United States More Info
Principal Investigator
Orlando Florida, 32804, United States More Info
Principal Investigator
Tampa Florida, 33612, United States More Info
Principal Investigator
Chicago Illinois, 60637, United States More Info
Principal Investigator
Glenn Dale Maryland, 20769, United States More Info
Principal Investigator
Minneapolis Minnesota, 55404, United States More Info
Principal Investigator
Saint Louis Missouri, 63110, United States More Info
Principal Investigator
Las Vegas Nevada, 89128, United States More Info
Principal Investigator
Albuquerque New Mexico, 87131, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
Cleveland Ohio, 44195, United States More Info
Principal Investigator
Columbus Ohio, 43212, United States More Info
Principal Investigator
Oklahoma City Oklahoma, 73104, United States More Info
Principal Investigator
Eugene Oregon, 97401, United States More Info
Principal Investigator
Portland Oregon, 97227, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Austin Texas, 78731, United States More Info
Principal Investigator
Dallas Texas, 75231, United States More Info
Principal Investigator
Dallas Texas, 75390, United States More Info
Principal Investigator
Longview Texas, 75601, United States More Info
Principal Investigator
McAllen Texas, 78503, United States More Info
Principal Investigator
San Antonio Texas, 78240, United States More Info
Principal Investigator
The Woodlands Texas, 77380, United States More Info
Principal Investigator
Charlottesville Virginia, 22908, United States More Info
Principal Investigator
Gainesville Virginia, 20155, United States More Info
Principal Investigator
Sub-Investigator
Gent , 9000, Belgium More Info
Principal Investigator
Montréal , H2X 0, Canada More Info
Principal Investigator
Toronto , M5G2M, Canada More Info
Principal Investigator
Milano , 20141, Italy More Info
Principal Investigator
Padova , 35128, Italy More Info
Principal Investigator
Barcelona , 08035, Spain More Info
Principal Investigator
Córdoba , 14004, Spain More Info
Principal Investigator
Madrid , 28034, Spain More Info
Principal Investigator
Valencia , 46010, Spain More Info
Contact
Principal Investigator
Edinburgh , EH4 2, United Kingdom More Info
Principal Investigator
Glasgow , G120Y, United Kingdom More Info
Principal Investigator
London , NW1 2, United Kingdom More Info
Principal Investigator
Manchester , M20 4, United Kingdom More Info
Principal Investigator
Sutton , , United Kingdom More Info
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