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Open-Label Extension Study to Provide Continued Access to Avutometinib Alone or in Combination with Defactinib in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
EU CTIS ID: 2025-524713-88-00
What this study is testing
To provide continued treatment with avutometinib alone or in combination with defactinib for participants with recurrent LGSOC who are deriving continued clinical benefit after completion of the RAMP-201 study.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Completion of the RAMP-201 study while receiving avutometinib alone or in combination with defactinib, meeting all requirements to transition directly into this OLE study without interruption of treatment. Participants must be deriving ongoing clinical benefit at the time of enrollment in this study (e.g., complete response, partial response, or stable disease), as determined by the investigator. Any active dose hold from the RAMP-201 study should be ≤28 days at the time of Screening for the OLE study.
- The Investigator determines that continued treatment is in the participant’s best interest and that the participant fulfills all protocol-defined criteria for continued treatment. Eligibility confirmation may be reviewed by the Sponsor to ensure consistency with the protocol.
- Female participants of childbearing potential must agree to use a highly effective method of contraception (Section 7.1) 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.
You likely can't join if
- Radiographic or clinical disease progression or discontinuation of treatment due to unacceptable toxicity during the RAMP-201 study or at the time of screening in this study.
- Participants on an active dose hold in the 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 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).
See the full eligibility criteria
Who can join
- Completion of the RAMP-201 study while receiving avutometinib alone or in combination with defactinib, meeting all requirements to transition directly into this OLE study without interruption of treatment. Participants must be deriving ongoing clinical benefit at the time of enrollment in this study (e.g., complete response, partial response, or stable disease), as determined by the investigator. Any active dose hold from the RAMP-201 study should be ≤28 days at the time of Screening for the OLE study.
- The Investigator determines that continued treatment is in the participant’s best interest and that the participant fulfills all protocol-defined criteria for continued treatment. Eligibility confirmation may be reviewed by the Sponsor to ensure consistency with the protocol.
- Female participants of childbearing potential must agree to use a highly effective method of contraception (Section 7.1) 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.
What rules you out
- Radiographic or clinical disease progression or discontinuation of treatment due to unacceptable toxicity during the RAMP-201 study or at the time of screening in this study.
- Participants on an active dose hold in the 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 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).
- 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) (Section 10.6).
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.