Sapanisertib, Carboplatin, and Paclitaxel in Treating Patients With Recurrent or Refractory Malignant Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Malignant Solid Neoplasm
- Refractory Malignant Solid Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 the...
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.
Tracking Information
- NCT #
- NCT03430882
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Vivek Subbiah M.D. Anderson Cancer Center