A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and in Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
- 试验地点
- 44
- 主要终点
- Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib
研究概览
简要总结
This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
详细描述
This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven LGSOC (ovarian, peritoneal)
- •Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
- •Measurable disease according to RECIST 1.1
- •An Eastern Cooperative Group (ECOG) performance status ≤
- •Adequate organ function
- •Adequate recovery from toxicities related to prior treatments
- •Agreement to use highly effective method of contraceptive, if necessary
排除标准
- •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 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
- •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
- •Subjects with the inability to swallow oral medications
研究组 & 干预措施
Part A
To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)
干预措施: avutometinib (VS-6766) (Drug)
Part A
To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)
干预措施: avutometinib (VS-6766) and defactinib (Drug)
Part B
To determine the efficacy of the optimal regimen identified from Part A
干预措施: avutometinib (VS-6766) (Drug)
Part B
To determine the efficacy of the optimal regimen identified from Part A
干预措施: avutometinib (VS-6766) and defactinib (Drug)
Part C:
To evaluate additional efficacy parameters for the optimal regimen identified in Part A.
干预措施: avutometinib (VS-6766) and defactinib (Drug)
Part D
To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
干预措施: avutometinib (VS-6766) and defactinib (Drug)
结局指标
主要结局
Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib
时间窗: From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
Part B: To determine the efficacy of the optimal regimen identified from Part A
时间窗: From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
Part C: To evaluate additional efficacy parameters for the optimal regimen identified in Part A
时间窗: From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
Part D:To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
时间窗: From start of treatment to confirmation of response; 24 weeks
Confirmed ORR defined according to RECIST 1.1
次要结局
- Overall Response Rate as assessed by Investigator(From start of treatment to confirmation of response; 24 weeks)
- Disease Control Rate (DCR)(Greater than or equal to 8 weeks)
- Overall Survival (OS)(Up to 5 years)
- Duration of Response (DOR)(Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 6 months)
- Progression Free Survival (PFS)(Up to 5 years)
研究者
研究点 (44)
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