Sapanisertib and Metformin in Treating Patients With Advanced or Metastatic Relapsed or Refractory Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 38
Summary
- Conditions
- Advanced Malignant Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
- Recurrent Malignant Solid Neoplasm
- Refractory 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 OBJECTIVES: I. To evaluate the safety and tolerability and to determine maximum tolerated dose (MTD) of the combination of sapanisertib (TAK-228) with metformin in patients with advanced cancers refractory to standard therapy. SECONDARY OBJECTIVES: I. To assess the clinical tumor response of...
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability and to determine maximum tolerated dose (MTD) of the combination of sapanisertib (TAK-228) with metformin in patients with advanced cancers refractory to standard therapy. SECONDARY OBJECTIVES: I. To assess the clinical tumor response of this combination. II. To characterize the pharmacokinetic (PK) profile of metformin and TAK-228. OUTLINE: This is a dose escalation study. Patients receive metformin orally (PO) 1-3 times daily on days 1-42 and sapanisertib PO daily on days 15-42 of cycle 1. Patients then receive metformin PO daily and sapanisertib PO daily on days 1-28 of cycle 2 and beyond. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 30 days.
Tracking Information
- NCT #
- NCT03017833
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Vivek Subbiah M.D. Anderson Cancer Center
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