TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors
Phase 1
Active, not recruiting
NCT02142803
| Condition | Adult Glioblastoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Ovarian Clear Cell Cystadenocarcinoma |
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| Phase | Phase 1 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 50 participants |
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| Interventions | Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study, Sapanisertib |
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| Start date | May 20, 2014 |
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| Completion date | Dec 31, 2020 |
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| Results posted | Oct 4, 2023 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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