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Looking for participantsPhase3

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

Sponsor: Verastem, Inc.

NCT ID: NCT06072781

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
avutometinib (drug), Defactinib (drug), Pegylated liposomal doxorubicin (drug), Paclitaxel (drug)
How long the study runs
Study runs about 83 months (dates as stated)
About the drug or intervention
avutometinib — drug: Avutometinib: administered orally · Defactinib — drug: Defactinib: administered orally · Pegylated liposomal doxorubicin — drug: administered intravenously · Paclitaxel — drug: administered intravenously · Letrozole — drug: administered orally · Anastrozole — drug: administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
270
Started
2024-03-18
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for low grade serous ovarian cancer
  • • Phase3 - 270 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with low grade serous ovarian cancer
  • • Female only

Where?

  • • Glasgow - Greater Glasgow and Clyde (GGC)
  • • Cambridge - Cambridge University Hospital
  • • Edinburgh - University of Edinburgh Cancer Research Centre
  • • Leicester - Hope Cancer Trials Centre
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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 types of drugs called kinase inhibitors. 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 four 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 standards 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)

Low Grade Serous Ovarian Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

KRAS

What the study is looking for

  • ✓Patients may be eligible for inclusion in the study if they meet the following criteria:
  • ✓Histologically proven LGSOC (ovarian, fallopian, peritoneal)
  • ✓Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
  • ✓Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin,...
  • ✓Progression or recurrence of LGSOC after at least one prior treatment that goes through your whole body for that has spread disease.

Who cannot take part

  • ✗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 serous ovarian cancer or mixed histology.
  • ✗Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
  • ✗History of prior cancer with recurrence \<3 years from the time of enrollment.
See the full criteria
Inclusion Criteria: Patients may be eligible for inclusion in the study if they meet the following criteria: 1. Histologically proven LGSOC (ovarian, fallopian, peritoneal) 2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test. 3. Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole. 4. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease. 5. Measurable disease according to RECIST v1.1. 6. An Eastern Cooperative Group (ECOG) performance status ≤ 1. 7. Adequate organ function. 8. Adequate recovery from toxicities related to prior treatments. 9. For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive. 10. 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: 1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy. 2. Co-existing high-grade serous ovarian cancer or mixed histology. 3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors. 4. History of prior malignancy with recurrence \<3 years from the time of enrollment. 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. Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression. 7. An active skin disorder that has required systemic therapy within one year of the first dose of study intervention. 8. History of medically significant rhabdomyolysis. 9. For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor. 10. Symptomatic bowel obstruction within 3 months of the first dose of study intervention 11. Concurrent ocular disorders. 12. Concurrent heart disease or severe obstructive pulmonary disease. 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. Subjects with the inability to swallow oral medications. 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. Pregnant or breastfeeding. 17. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Where Is This Study? (8 UK sites)

Greater Glasgow and Clyde (GGC)

Glasgow G120YN, United Kingdom

Recruiting
Site contact (verified)
Ros Glasspool, MDPrincipal Investigator

Cambridge University Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Joo Ern Ang, MDPrincipal Investigator
Regulatory Teamcuh.research@nhs.net

University of Edinburgh Cancer Research Centre

Edinburgh, United Kingdom

Recruiting
Site contact (verified)
Charlie Gourley, MDPrincipal Investigator

Hope Cancer Trials Centre

Leicester LE2 7LX, United Kingdom

Recruiting
Site contact (verified)
Joey Wood, MDPrincipal Investigator

University College London Hospitals NHS Foundation Trust

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Rowan Miller, MDPrincipal Investigator
Christian Paul Medinachristianpaul.medina@nhs.net
Shibani Nicum, MDsnicum@nhs.net

Royal Marsden Hospital

London SW7 3RP, United Kingdom

Recruiting
Site contact (verified)
Susana Banerjee, MDPrincipal Investigator

The Christie NHS Foundation Trust

Manchester, United Kingdom

Recruiting
Site contact (verified)
Andrew Clamp, MDPrincipal Investigator

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Susana Banerjee, MDPrincipal Investigator

How to Get in Touch

Verastem Call Center

Sponsor contact

CONTACT

781-292-4204 RAMP301TrialSupport@verastem.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10