TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors
第1相
実施中(募集終了)
NCT02142803
| 対象疾患 | Adult Glioblastoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Ovarian Clear Cell Cystadenocarcinoma |
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| 相 | 第1相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 50 名 |
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| 介入(薬剤) | Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study, Sapanisertib |
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| 開始日 | 2014年5月20日 |
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| 完了日 | 2020年12月31日 |
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| 結果公開日 | 2023年10月4日 |
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概要
This phase I trial studies the side effects and best dose of raptor/rictor-mammalian target of rapamycin (mTOR) (TORC1/2) inhibitor MLN0128 when given in combination with bevacizumab in treating patients with glioblastoma, a type of brain tumor, or a solid tumor that has spread and not responded to standard treatment. TORC1/2 inhibitor MLN0128 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the progression of tumors by blocking the growth of new blood vessels necessary for tumor growth.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) of Daily Oral MLN0128 When Administered With Bevacizumab
28 days · mg/day
| Stage 1: Dose Escalation to Estimate MTD/RP2D | 5 mg/day |
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Most Common Related Toxicities That Led to Dose Hold/Reductions
Up to 2 years · participants
| Dose Level 1 - 3 mg MLN0128 Daily | 0 participants |
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| Dose Level 2 - 4 mg MLN0128 Daily | 0 participants |
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| Dose Level 3 - 5 mg MLN0128 Daily | 2 participants |
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| Dose Level 1 - 3 mg MLN0128 Daily | 0 participants |
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| Dose Level 2 - 4 mg MLN0128 Daily | 0 participants |
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| Dose Level 3 - 5 mg MLN0128 Daily | 1 participants |
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