Low Grade Ovarian Serous AdenocarcinomaPhase 2NCT07747506
Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
A Phase 2 study testing avutometinib + defactininb combination in people with Low Grade Ovarian Serous Adenocarcinoma and Ovarian Cancer, run by Verastem, Inc. at 2 sites in France.
Trial summary
This Open-Label Extension (OLE) study provides participants with recurrent low-grade serous ovarian cancer (LGSOC) who have completed the VS-6766-201(RAMP-201) study continued, uninterrupted access to avutometinib in combination with defactinib. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Low Grade Ovarian Serous Adenocarcinoma, Ovarian Cancer
- What is being tested?
- avutometinib + defactininb combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Aug 2026to 1 Aug 2028
- 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
- Currently active on VS-6766-201(RAMP-201) study while receiving avutometinib in combination with defactinib, have not required prior permanent discontinuation of avutometinib plus defactinib. Any active dose hold from the RAMP-201 study should be ≤ 28 days at the time of Screening for the OLE study.
- Investigator assessment that the participant is deriving clinical benefit from study treatment (e.g., complete response, partial response, or stable disease), as determined by the investigator.
- Female participants of childbearing potential must agree to use a highly effective method of contraception throughout OLE study participation and for at least 30 days after the last dose of study treatment.
- Note: Female participants of childbearing potential must have a negative serum or urine pregnancy test at Screening/Eligibility prior to the first OLE dose.
- Ability and willingness to provide written informed consent for participation in the study and for continued data collection.
Who cannot join
- Radiographic or clinical disease progression or discontinuation of treatment for any reason during the VS-6766-201 (RAMP-201) study or at the time of screening in this study.
- Participants on an active dose hold in the VS-6766-201 (RAMP-201) study may transition to this study only after the underlying issue has been clinically resolved and the investigator, in consultation with the Sponsor, confirms that continued treatment is appropriate.
- Receipt of new systemic anti-cancer therapy since participation in the RAMP-201 study.
- Participation in another interventional clinical study or receipt of other investigational therapy since participation in VS-6766-201 (RAMP-201) study.
- Any active or uncontrolled medical condition that, in the investigator's judgment, would pose unacceptable risk or interfere with continued treatment, including but not limited to severe cardiac, pulmonary, neurologic, dermatologic, gastrointestinal, hepatic, or active infectious disease.
- Any active or history of clinically significant ocular disorder that may increase the risk of MEK-inhibitor-related ocular toxicity (e.g., retinal vein occlusion, serous retinopathy, retinal detachment, or clinically significant macular pathology).
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- Concomitant use of medications known to have clinically significant interactions with avutometinib or defactinib that cannot be safely discontinued or substituted prior to study dosing (e.g., strong CYP3A4 inducers or inhibitors, warfarin).
- Positive pregnancy test at Screening, breastfeeding, or unwillingness to use adequate contraception during the study.
- Any condition or circumstance that, in the investigator's opinion, may compromise participant safety, compliance or continued benefit from study treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Centre Leon Berard
Lyon, 69008
Isabelle Ray-Coquard, MD, +33 478782888/5912, isabelle.ray-coquard@lyon.unicancer.fr
Isabelle Ray-Coquard, MD
Institut Curie
Paris, 75248
Manuel Rodrigues, MD, manuel.rodrigues@curie.fr
Manuel Rodrigues, MD
About this study
Official title: Open-Label Extension Study to Provide Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
This Open-Label Extension (OLE) study provides participants with recurrent low-grade serous ovarian cancer (LGSOC) who have completed the VS-6766-201(RAMP-201) study continued, uninterrupted access to avutometinib in combination with defactinib. The study is designed to support patients in France with access to avutometinib and defactinib who maintain ongoing clinical benefit while collecting safety and tolerability data during extended treatment. Participation is restricted to patients transferring directly from VS-6766-201(RAMP-201), ensuring continuity of care without enrollment of new patients.
- Being tested
- avutometinib + defactininb combination
- Keywords
- Low Grade Serous Ovarian Cancer, Recurrent Low-Grade Serous Ovarian Cancer, KRAS, KRAS wt, KRAS mt, LGSOC
- 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 + defactininb combinationDrug
Also called avutometinib (VS-6766) and defactinib (VS-6063)
Avutometinib: administered orally twice a week
Defactinib: administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Continued Treatment of Avutometinib + Defactinib | Experimental | To provide continued treatment with avutometinib in combination with defactinib for participants with recurrent LGSOC who are deriving continued clinical benefit after completion of the VS-6766-201 (RAMP-201) study Receives: Drug: avutometinib + defactininb combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Treatment Exposure to Avutometinib in Combination With Defactinib
Treatment exposure will be summarized descriptively for participants receiving continued treatment with avutometinib in combination with defactinib after completion of Study VS-6766-201 (RAMP-201).
Measured: Until treatment discontinuation (approximately 20 months)
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Treatment-emergent adverse events will be collected and summarized for participants receiving extended treatment with avutometinib alone or in combination with defactinib.
Measured: From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Ovarian Serous AdenocarcinomaStudies 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
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verastem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD Verastem, Study director, Verastem Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747506
- Sponsor's protocol ID
- VS-6766-206
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension Study to Provide Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
- ClinicalTrials.gov ID
- NCT07747506
- Acronym / sponsor ID
- VS-6766-206
- Keywords
- Low Grade Serous Ovarian Cancer, Recurrent Low-Grade Serous Ovarian Cancer, KRAS, KRAS wt, KRAS mt, LGSOC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Verastem, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 5 Aug 2026 (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 Open-Label Extension (OLE) study provides participants with recurrent low-grade serous ovarian cancer (LGSOC) who have completed the VS-6766-201(RAMP-201) study continued, uninterrupted access to avutometinib in combination with defactinib. The study is designed to support patients in France with access to avutometinib and defactinib who maintain ongoing clinical benefit while collecting safety and tolerability data during extended treatment. Participation is restricted to patients transferring directly from VS-6766-201(RAMP-201), ensuring continuity of care without enrollment of new patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continued Treatment of Avutometinib + Defactinib | Experimental | Drug: avutometinib + defactininb combinationTo provide continued treatment with avutometinib in combination with defactinib for participants with recurrent LGSOC who are deriving continued clinical benefit after completion of the VS-6766-201 (RAMP-201) study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently active on VS-6766-201(RAMP-201) study while receiving avutometinib in combination with defactinib, have not required prior permanent discontinuation of avutometinib plus defactinib. Any active dose hold from the RAMP-201 study should be ≤ 28 days at the time of Screening for the OLE study.
- Investigator assessment that the participant is deriving clinical benefit from study treatment (e.g., complete response, partial response, or stable disease), as determined by the investigator.
- Female participants of childbearing potential must agree to use a highly effective method of contraception throughout OLE study participation and for at least 30 days after the last dose of study treatment.
- Note: Female participants of childbearing potential must have a negative serum or urine pregnancy test at Screening/Eligibility prior to the first OLE dose.
- Ability and willingness to provide written informed consent for participation in the study and for continued data collection.
Key exclusion criteria (9 listed)
- Radiographic or clinical disease progression or discontinuation of treatment for any reason during the VS-6766-201 (RAMP-201) study or at the time of screening in this study.
- Participants on an active dose hold in the VS-6766-201 (RAMP-201) study may transition to this study only after the underlying issue has been clinically resolved and the investigator, in consultation with the Sponsor, confirms that continued treatment is appropriate.
- Receipt of new systemic anti-cancer therapy since participation in the RAMP-201 study.
- Participation in another interventional clinical study or receipt of other investigational therapy since participation in VS-6766-201 (RAMP-201) study.
- Any active or uncontrolled medical condition that, in the investigator's judgment, would pose unacceptable risk or interfere with continued treatment, including but not limited to severe cardiac, pulmonary, neurologic, dermatologic, gastrointestinal, hepatic, or active infectious disease.
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 + defactininb combinationAlso: avutometinib (VS-6766) and defactinib (VS-6063)Avutometinib: administered orally twice a week Defactinib: administered orally twice daily | Drug | Continued Treatment of Avutometinib + Defactinib |
Primary outcome
Duration of Treatment Exposure to Avutometinib in Combination With Defactinib
Time frame: Until treatment discontinuation (approximately 20 months)
Treatment exposure will be summarized descriptively for participants receiving continued treatment with avutometinib in combination with defactinib after completion of Study VS-6766-201 (RAMP-201).
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
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 5 Aug 2026.
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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.
MD Verastem study director
Verastem Oncology
2 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 + defactininb combination in people with Low Grade Ovarian Serous Adenocarcinoma and Ovarian Cancer, run by Verastem, Inc. at 2 sites in France.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Contact Verastem Call Center (781-292-4204, clinicaltrials@verastem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Treatment Exposure to Avutometinib in Combination With Defactinib (time frame: Until treatment discontinuation (approximately 20 months)). 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 5 Aug 2026.