Trials / Completed
CompletedNCT03017833
Sapanisertib and Metformin in Treating Patients With Advanced or Metastatic Relapsed or Refractory Cancers
Phase I Study of TAK-228 (MLN0128) in Combination With Metformin in Patients With Advanced Cancers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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 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.
Conditions
- Advanced Malignant Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
- Recurrent Malignant Solid Neoplasm
- Refractory Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| DRUG | Metformin | Given PO |
| OTHER | Pharmacological Study | Ancillary studies |
| DRUG | Sapanisertib | Given PO |
Timeline
- Start date
- 2018-03-12
- Primary completion
- 2022-12-21
- Completion
- 2022-12-21
- First posted
- 2017-01-11
- Last updated
- 2023-10-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03017833. Inclusion in this directory is not an endorsement.