EUCTR2020-002250-24-AT进行中（未招募）1 期
GCAR-7213: 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), Version 3.2, Amendment 2.2, 14Apr2021APPENDIX A: ARM/ STUDY STATUS SUMMARY, Version 3.2, Amendment 2.2, 14Apr2021APPENDIX B: CONTROL ARM - TEMOZOLOMIDE (TMZ) AND LOMUSTINE (CCNU) STANDARD OF CARE, Version 3.2, Amendment 2.2, 14Apr2021APPENDIX C: REGORAFENIB (BAY 73-4506) - INVESTIGATIONAL AGENT INFORMATION SUMMARY, Version 3.2, Amendment 2.2, 14Apr2021Protocol Clarification Letter - Re: GBM AGILE; Protocol Clarification Letter: Regorafenib Investigator’s Brochure v17.0Contraception Language, dated 22Dec2020 - GBM AGILE: Glioblastoma Adaptive Global Innovative Learning Environment
Global Coalition for Adaptive Research0 个研究点目标入组 355 人开始时间: 2021年5月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 355
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Main Inclusion Criteria - Newly Diagnosed:
- •Age = 18 years.
- •Histologically confirmed Grade IV GBM/gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy.
- •- An MRI scan performed within 21 days prior to randomization preferably.
- •Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization.
- •Karnofsky performance status = 60% performed within a 14-day window
- •prior to randomization.
- •Availability of tumor tissue representative of GBM from definitive surgery or biopsy.
- •Main Inclusion Criteria - Recurrent:
- •Age = 18 years.
- •Histologically confirmed GBM/gliosarcoma (WHO criteria; non-IDH R132H mutant) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum Radiation Therapy (RT).
- •Evidence of recurrent disease (RD) demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
- •Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization.
- •Baseline MRI performed within 14 days prior to randomization.
- •Karnofsky performance status = 70% performed within a 14-day window
- •prior to randomization.
- •Availability of tumor tissue representative of GBM from initial definitive
- •surgery and/or, recurrent surgery, if performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 277
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •Main Exclusion Criteria - Newly Diagnosed:
- •Any prior treatment for glioma including: prior prolifeprospan 20 with
- •carmustine wafer; prior intracerebral agent; prior radiation treatment for
- •GBM or lower-grade glioma; prior chemotherapy or immunotherapy for
- •GBM or lower-grade glioma.
- •Receiving additional, concurrent, active therapy for GBM outside of the trial
- •Extensive leptomeningeal disease.
- •QTc > 450 msec if male and QTc > 470 msec if female.
- •History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
- •Laboratory results that meet exclusionary parameters.
- •Main Exclusion Criteria - Recurrent Exclusion Criteria:
- •Early disease progression prior to 3 months (12 weeks) from the
- •completion of RT.
- •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.).
- •Any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other VEG)- or VEGF receptor-mediated targeted agent.
- •Any prior treatment with prolifeprospan 20 with carmustine wafer.
- •Any prior treatment with an intracerebral agent.
- •Receiving additional, concurrent, active therapy for GBM outside of the trial.
- •Extensive leptomeningeal disease.
- •QTc > 450 msec if male and QTc > 470 msec if female.
- •History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Participant with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
- •Laboratory results that meet exclusionary parameters.
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