RECRUITING

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

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Conditions

Low Grade Serous Ovarian CancerKRASKRAS wtKRAS mt

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

Quick Facts

Study Start:2024-03-18
Study Completion:2031-02-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06072781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically proven LGSOC (ovarian, fallopian, peritoneal)
  2. 2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
  3. 3. Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
  4. 4. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
  5. 5. Measurable disease according to RECIST v1.1.
  6. 6. An Eastern Cooperative Group (ECOG) performance status ≤ 1.
  7. 7. Adequate organ function.
  8. 8. Adequate recovery from toxicities related to prior treatments.
  9. 9. For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
  10. 10. Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
  1. 1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
  2. 2. Co-existing high-grade serous ovarian cancer or mixed histology.
  3. 3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
  4. 4. History of prior malignancy with recurrence \<3 years from the time of enrollment.
  5. 5. Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
  6. 6. Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
  7. 7. An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
  8. 8. History of medically significant rhabdomyolysis.
  9. 9. For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
  10. 10. Symptomatic bowel obstruction within 3 months of the first dose of study intervention
  11. 11. Concurrent ocular disorders.
  12. 12. Concurrent heart disease or severe obstructive pulmonary disease.
  13. 13. Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
  14. 14. Subjects with the inability to swallow oral medications.
  15. 15. History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.
  16. 16. Pregnant or breastfeeding.
  17. 17. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Contacts and Locations

Study Contact

Verastem Call Center
CONTACT
781-292-4204
RAMP301TrialSupport@verastem.com

Principal Investigator

Rachel Grisham, MD
PRINCIPAL_INVESTIGATOR
GOG Foundation
Susana Banerjee, MBBS, MA, PhD
PRINCIPAL_INVESTIGATOR
European Network of Gynecological Oncological Trial Groups (ENGOT)
Melina Arazy, MD Verastem Medical Monitor
STUDY_DIRECTOR
RAMP301@verastem.com

Study Locations (Sites)

HonorHealth
Phoenix, Arizona, 85016
United States
University of Arkansas
Little Rock, Arkansas, 72205
United States
UCLA Health
Los Angeles, California, 90095
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Yale University
New Haven, Connecticut, 06520
United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
United States
Mount Sinai
Miami Beach, Florida, 33140
United States
AdventHealth
Orlando, Florida, 32804
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Florida Cancer Specialists Research East
West Palm Beach, Florida, 33401
United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322
United States
NorthShore University HealthSystem
Evanston, Illinois, 60201
United States
Louisiana State University
New Orleans, Louisiana, 70112
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States
Karmanos Cancer Center
Detroit, Michigan, 48201
United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Atrium Health
Charlotte, North Carolina, 28203
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio State
Hilliard, Ohio, 43026
United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
United States
Willamette Valley Cancer Institute
Eugene, Oregon, 97401
United States
Northwest Cancer Specialists
Portland, Oregon, 97227
United States
Asplundh Cancer Pavilion | Jefferson Health
Philadelphia, Pennsylvania, 19090
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
United States
Texas Oncology Central
Austin, Texas, 78731
United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, 76104
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology
San Antonio, Texas, 78229
United States
Texas Oncology
The Woodlands, Texas, 77380
United States
Texas Oncology
Tyler, Texas, 75702
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, 20155
United States

Collaborators and Investigators

Sponsor: Verastem, Inc.

  • Rachel Grisham, MD, PRINCIPAL_INVESTIGATOR, GOG Foundation
  • Susana Banerjee, MBBS, MA, PhD, PRINCIPAL_INVESTIGATOR, European Network of Gynecological Oncological Trial Groups (ENGOT)
  • Melina Arazy, MD Verastem Medical Monitor, STUDY_DIRECTOR, RAMP301@verastem.com

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-18
Study Completion Date2031-02-09

Study Record Updates

Study Start Date2024-03-18
Study Completion Date2031-02-09

Terms related to this study

Keywords Provided by Researchers

  • Low Grade Serous Ovarian Cancer
  • KRAS
  • KRAS wt
  • KRAS mt

Additional Relevant MeSH Terms

  • Low Grade Serous Ovarian Cancer