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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (8 UK sites)
Greater Glasgow and Clyde (GGC)
Glasgow G120YN, United Kingdom
Cambridge University Hospital
Cambridge CB2 0QQ, United Kingdom
University of Edinburgh Cancer Research Centre
Edinburgh, United Kingdom
Hope Cancer Trials Centre
Leicester LE2 7LX, United Kingdom
University College London Hospitals NHS Foundation Trust
London NW1 2PG, United Kingdom
Royal Marsden Hospital
London SW7 3RP, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
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