BENITIONSClinical Trial Intelligence

TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors

1상 진행 중(모집 완료) NCT02142803

대상 질환Adult Glioblastoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Ovarian Clear Cell Cystadenocarcinoma
임상 단계1상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수50 명
중재(약물)Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study, Sapanisertib
시작일2014년 5월 20일
완료일2020년 12월 31일
결과 공개일2023년 10월 4일

요약

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/RP2D5 mg/day

Most Common Related Toxicities That Led to Dose Hold/Reductions

Up to 2 years · participants

Dose Level 1 - 3 mg MLN0128 Daily0 participants
Dose Level 2 - 4 mg MLN0128 Daily0 participants
Dose Level 3 - 5 mg MLN0128 Daily2 participants
Dose Level 1 - 3 mg MLN0128 Daily0 participants
Dose Level 2 - 4 mg MLN0128 Daily0 participants
Dose Level 3 - 5 mg MLN0128 Daily1 participants

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