Phase I Study of TAK-228 (MLN0128) in Combination With Metformin in Patients With Advanced Cancers
Abstract
This phase I trial studies the side effects and best dose of sapanisertib and metformin in treating patients with cancers that have spread to other parts of the body (advanced/metastatic), have come back (recurrent), or do not respond to treatment (refractory). Sapanisertib and metformin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Refractory Neoplasm.
Primary outcome: Incidence of serious adverse events; Clinical and laboratory values; Vital sign measurements; GI symptoms; Incidence of neurotoxicity.
Enrollment: 31 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 31 participants or records.
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