Low Grade Serous Ovarian CancerPhase 2RAMP201JNCT06682572
A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients
A Phase 2 study testing Avutometinib (VS-6766) + Defactinib (VS-6063) in people with Low Grade Serous Ovarian Cancer and Ovarian Cancer, run by Verastem, Inc. at 5 sites in Japan.
Trial summary
This study will confirm the safety and efficacy of avutometinib in combination with defactinib in Japanese patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Low Grade Serous Ovarian Cancer, Ovarian Cancer
- What is being tested?
- Avutometinib (VS-6766) + Defactinib (VS-6063)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesJapan
- Study dates
- 30 Oct 2024to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven LGSOC (ovarian, peritoneal)
- Documented mutational status of KRAS by validated diagnostic test of tumor tissue
- Documented disease progression (radiographic or clinical) or recurrence of LGSOC and have received at least one platinum-based chemotherapy agent
- 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
Who cannot join
- 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, excluding ovarian cancer, 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
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- 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
- Patients with the inability to swallow oral medications
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Jikei University Hospital
Minato, Tokyo, 105-0003
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Mie University Hospital
Tsu, Mie-ken, 514-8507
About this study
Official title: A Phase 2 Study of Avutometinib (VS-6766, a Dual RAF/MEK Inhibitor) In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Japanese Patients
This study will confirm the safety and efficacy of avutometinib in combination with defactinib in Japanese patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Read the detailed description
This is a multi-center, open label Phase 2 study designed to evaluate safety and tolerability and confirm efficacy by BICR of avutometinib in combination with defactinib in Japanese patients with molecularly profiled recurrent LGSOC.
- Conditions
- Low Grade Serous Ovarian Cancer, Ovarian Cancer
- Being tested
- Avutometinib (VS-6766) + Defactinib (VS-6063)
- Keywords
- KRAS, KRAS wt, KRAS mt
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avutometinib (VS-6766) + Defactinib (VS-6063)Drug
combination therapy
| Study group | Role | What they receive |
|---|---|---|
| avutometinib + defactinib | Experimental | Avutometinib 3.2mg, PO, twice weekly for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day (4 week) cycle. Receives: Drug: Avutometinib (VS-6766) + Defactinib (VS-6063) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed overall response rate (ORR; partial response [PR] + complete response [CR]
Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) as assessed by the blinded independent central radiology review committee (BICR)
Measured: From start of treatment to confirmation of response; 24 weeks
Secondary outcomes (9)
Duration of Response
From the time of first dose of study intervention to PD as assessed by RECIST 1.1 or death from any cause
Measured: 12 months
Objective response rate (ORR)
From the time of first dose of study intervention to PD as assessed by RECIST 1.1 by Investigator or death from any cause.
Measured: 12 months
Progression free survival (PFS)
From the time of first dose of study intervention to first documentation of progressive disease (PD) or death by any cause
Measured: 24 months
Disease control rate (DCR)
CR + PR + SD
Measured: 6 months
Clinical benefit rate
CR + PR + (SD >6 months)
Measured: 6 months
Overall Survival (OS)
From the time of first dose of study intervention to PD as assessed by RECIST 1.1 or death from any cause
Measured: up to 2 years
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Count of AE and SAEs by grade, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale
Measured: 18 months
Area under the plasma concentration-time curve (AUC) of avutometinib, defactinib and relative metabolites
Area under Plasma Concentration (AUC) 0 to t
Measured: 9 months
Maximum plasma concentration (Cmax) of avutometinib, defactinib and relative metabolites
Maximum Plasma Concentration
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start30 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Serous Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Verastem, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verastem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Japanese Gynecologic Oncology Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682572
- Sponsor's protocol ID
- VS-6766-201J
- Other IDs
- jRCT2021240021
- Acronym
- RAMP201J
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Avutometinib (VS-6766, a Dual RAF/MEK Inhibitor) In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Japanese Patients
- ClinicalTrials.gov ID
- NCT06682572
- Acronym / sponsor ID
- RAMP201J / VS-6766-201J
- Conditions
- Low Grade Serous Ovarian Cancer, Ovarian Cancer
- Keywords
- KRAS, KRAS wt, KRAS mt
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Verastem, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Japanese Gynecologic Oncology Group
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will confirm the safety and efficacy of avutometinib in combination with defactinib in Japanese patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Detailed description
This is a multi-center, open label Phase 2 study designed to evaluate safety and tolerability and confirm efficacy by BICR of avutometinib in combination with defactinib in Japanese patients with molecularly profiled recurrent LGSOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| avutometinib + defactinib | Experimental | Drug: Avutometinib (VS-6766) + Defactinib (VS-6063)Avutometinib 3.2mg, PO, twice weekly for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day (4 week) cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven LGSOC (ovarian, peritoneal)
- Documented mutational status of KRAS by validated diagnostic test of tumor tissue
- Documented disease progression (radiographic or clinical) or recurrence of LGSOC and have received at least one platinum-based chemotherapy agent
- Measurable disease according to RECIST 1.1
- An Eastern Cooperative Group (ECOG) performance status ≤ 1.
Key exclusion criteria (12 listed)
- 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, excluding ovarian cancer, with recurrence <3 years from the time of enrollment
- Major surgery within 4 weeks
- Symptomatic brain metastases requiring steroids or other interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avutometinib (VS-6766) + Defactinib (VS-6063)combination therapy | Drug | avutometinib + defactinib |
Primary outcome
Confirmed overall response rate (ORR; partial response [PR] + complete response [CR]
Time frame: From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) as assessed by the blinded independent central radiology review committee (BICR)
9 secondary outcomes
Duration of Response
Time frame: 12 months
Objective response rate (ORR)
Time frame: 12 months
Progression free survival (PFS)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 6 months
Clinical benefit rate
Time frame: 6 months
Overall Survival (OS)
Time frame: up to 2 years
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 18 months
Area under the plasma concentration-time curve (AUC) of avutometinib, defactinib and relative metabolites
Time frame: 9 months
Maximum plasma concentration (Cmax) of avutometinib, defactinib and relative metabolites
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avutometinib (VS-6766) + Defactinib (VS-6063) in people with Low Grade Serous Ovarian Cancer and Ovarian Cancer, run by Verastem, Inc. at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] (time frame: From start of treatment to confirmation of response; 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.