Refractory Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase I Study of TAK-228 (MLN0128) in Combination With Carboplatin Plus Paclitaxel in Patients With Advanced Malignancies
This phase I trial studies the sides effects and best dose of sapanisertib, carboplatin, and paclitaxel in treating patients with malignant solid tumors that have come back (recurrent) or do not respond to treatment (refractory). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing cells, by stopping them from dividing, or by stopping them from spreading. Giving sapanisertib, carboplatin, and paclitaxel may work better in treating patients with malignant solid tumors.
PRIMARY OBJECTIVE: I. To determine the safety and tolerability of the combination of sapanisertib (TAK-228 [MLN0128]) plus paclitaxel, when given with carboplatin, and to determine the optimal dose triplet, or maximum tolerated dose (MTD), in patients with advanced cancers refractory to standard therapy. SECONDARY OBJECTIVES: I. To assess the clinical tumor response of this combination. II. To assess toxicity of this combination. III. To assess progression free survival. IV. To assess molecular signatures predictive of sensitivity and resistance. OUTLINE: This is a dose escalation study. Patients receive sapanisertib orally (PO) once daily (QD) on days 2-4, 9-11, and 16-18, paclitaxel intravenously (IV) over 3 hours on days 1, 8, and 15, and carboplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically. ;
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