Tests avutometinib with defactinib in recurrent low-grade serous ovarian cancer
Tests avutometinib plus defactinib against standard treatments in adults with returning ovarian cancer.
Plain-language title generated from the registry record
Registry title: A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
Key facts
- Where
- Bialystok, Gdansk, and Siedlce, PolandSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 or older whose low-grade serous ovarian cancer (LGSOC) has come back or got worse after earlier treatment. It compares avutometinib plus defactinib with the doctor's choice of treatment.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Low-grade serous ovarian cancer (ovarian, fallopian or peritoneal) that has progressed or come back; measurable disease (RECIST v1.1); ECOG performance status of 1 or lower
- Earlier treatment
- Must have had at least one earlier systemic treatment for metastatic disease. Cannot have had avutometinib, defactinib or other FAK inhibitors. No anti-cancer drug treatment within 4 weeks of the first dose.
- Biomarker or test result
- KRAS mutation status must be documented by a validated tumour-tissue test
Main reasons for not taking part
- Also has high-grade serous ovarian cancer or mixed histology
- Earlier cancer that came back less than 3 years before joining
- Brain metastases with symptoms, leptomeningeal metastases or spinal cord compression
- Interstitial lung disease or pneumonitis, now or in the past
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Where in Poland
- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w BialymstokuBialystok, PolandTaking people
- Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
- Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.Siedlce, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Verastem, Inc.
- Trial code
- NCT06072781EU 2023-508204-38-00
- Record updated
- 2 November 2026
- Original 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.Read full original descriptionShow less
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)
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.
Inclusion: 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, paclitaxel, letrozole, anastrozole; Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease; Measurable disease according to RECIST v1.1; An Eastern Cooperative Group (ECOG) performance status ≤ 1; Adequate organ function; Adequate recovery from toxicities related to prior treatments; For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive; Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion: Prior treatment with avutometinib, defactinib, or other FAK inhibitors; Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention; Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression; For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor; Concurrent ocular disorders; Concurrent heart disease or severe obstructive pulmonary disease; Subjects with the inability to swallow oral medications; 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; Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy; Co-existing high-grade serous ovarian cancer or mixed histology; An active skin disorder that has required systemic therapy within one year of the first dose of study intervention; History of medically significant rhabdomyolysis; Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS); Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy; History of prior malignancy with recurrence <3 years from the time of enrollment; Patients will be excluded from the study if they meet any of the following criteria:; Symptomatic bowel obstruction within 3 months of the first dose of study intervention; Pregnant or breastfeeding.