Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
1期
进行中(已停止招募)
NCT04477200
| 适应症 | Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma |
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| 分期 | 1期 |
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| 申办方 | University of Michigan Rogel Cancer Center |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 68 人 |
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| 干预(药物) | Mycophenolate Mofetil, Radiation Therapy, Re-resection (as part of standard of care), Temozolomide, Mycophenolate Mofetil |
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| 开始日期 | 2020年8月5日 |
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| 完成日期 | 2025年1月6日 |
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| 结果公布日 | 2026年5月14日 |
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摘要
This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma or gliosarcoma.
Concentration of Mycophenolic Acid (MPA) in Tumor Tissue in Phase 0 Participants
At 1 week · nmol/g
| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | 1.87 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | 2.65 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | 2.65 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | 1.8 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | 1.11 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | 0.81 nmol/g |
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Number of Recurrent Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level
Up to 28 days following completion of MMF + RT (up to ~9 weeks) · number of patients reporting a DLT
| Phase 1 - Recurrent GBM / GS - Level 3 | 0 number of patients reporting a DLT |
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| Phase 1 - Recurrent GBM / GS - Level 4 | 0 number of patients reporting a DLT |
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| Phase 1 - Recurrent GBM / GS - Level 5 | 0 number of patients reporting a DLT |
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Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT1 Period
Up to 28 days following completion of MMF + RT + TMZ (up to ~11 weeks) · number of patients reporting a DLT
| Phase 1 - Newly Diagnosed GBM / GS - Level 3 | 0 number of patients reporting a DLT |
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| Phase 1 - Newly Diagnosed GBM / GS- Level 4 | 0 number of patients reporting a DLT |
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| Phase 1 - Newly Diagnosed GBM / GS- Level 5 | 5 number of patients reporting a DLT |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。