2024-511452-40-00暂停3 期
GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Overall Survival defined from the time of randomization to death from any cause
研究概览
简要总结
- To identify experimental therapies that improve overall survival (OS) for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment
- To confirm identified efficacious experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •All patients: Age ≥ 18 years
- •Recurrent: Baseline MRI performed within 14 days prior to randomization
- •Recurrent: Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization
- •Recurrent: Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed.
- •Newly Diagnosed: Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy. A diagnosis made based on molecular characteristics alone is not allowed
- •Newly Diagnosed: An MRI scan performed within 21 days prior to randomization preferably
- •Newly Diagnosed: Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization
- •Newly Diagnosed: Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization
- •Newly Diagnosed: Availability of tumor tissue representative of GBM from definitive surgery or biopsy.
- •Recurrent: Histologically confirmed GBM, inclusive of gliosarcoma (WHO criteria 2016; IDH wild-type) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum Radiation Therapy (RT). (prior therapy with proton radiation or short course radiation is acceptable)
- •Recurrent: Evidence of recurrent disease (RD) demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria
- •Recurrent: Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization
排除标准
- •Newly Diagnosed: Any prior treatment for glioma including: prior prolifeprospan 20 with carmustine wafer; prior intracerebral agent; intratumoral, or cerebral spinal fluid (CSF) agent; prior radiation treatment (including proton radiation and short course radiation) for GBM or lower-grade glioma; prior chemotherapy or immunotherapy for GBM or lower-grade glioma
- •Newly Diagnosed: QTc > 450 msec if male and QTc > 470 msec if female
- •Newly Diagnosed: History of another malignancy in the previous 2 years, with a diseasefree interval of < 2 years. Note: Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible
- •Recurrent: Early disease progression prior to 3 months (12 weeks) from the completion of RT
- •Recurrent: More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of Temozolomide (TMZ) with an experimental agent is considered one line of chemotherapy)
- •Recurrent: Any prior treatment with lomustine, experimental agents currently enrolling in the GBM AGILE trial, and bevacizumab or other VEGF)- or VEGF receptor-mediated targeted agent
- •Recurrent: Any prior treatment with prolifeprospan 20 with carmustine wafer
- •Recurrent: Any prior treatment with an intracerebral agent
- •Recurrent: Receiving additional, concurrent, active therapy (including experimental) for GBM outside of the trial
- •Recurrent: Extensive leptomeningeal disease
- •Recurrent: QTc > 450 msec if male and QTc > 470 msec if female
- •Recurrent: History of another malignancy in the previous 2 years, with a diseasefree interval of < 2 years. Note: Participants with prior history of in situ cancer or basal or squamous cell skin cancer are eligible
- •Newly Diagnosed: Receiving additional, concurrent, active therapy (including experimental) for GBM outside of the trial
- •Newly Diagnosed: Extensive leptomeningeal disease Leptomeningeal disease in the region of the primary tumor and confined to the supratentorial area is allowed
结局指标
主要结局
Overall Survival defined from the time of randomization to death from any cause
Overall Survival defined from the time of randomization to death from any cause
次要结局
- Progression-Free Survival defined as the time from randomization to clinically determined progression or death from any cause
- Tumor Response: complete response, partial response, progressive disease, stable disease
- Duration of Response: - Complete Response and Partial Response defined as time from date of response to date of clinically determined disease progression or death from any cause
研究者
Regulatory Affairs
Scientific
Global Coalition For Adaptive Research Inc.
研究点 (10)
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