2025-524713-88-00招募中2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Investigator’s determination of ongoing clinical benefit
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
VS-6063
Test
干预措施: VS-6063 (Drug)
VS-6766
Test
干预措施: VS-6766 (Drug)
结局指标
主要结局
Investigator’s determination of ongoing clinical benefit
Investigator’s determination of ongoing clinical benefit
次要结局
- Frequency and severity of side effects, including abnormal findings from laboratory tests or physical examinations
研究者
Medical Affairs
Scientific
Verastem Inc.
研究点 (2)
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