Metastatic Urothelial Carcinoma Clinical Trial
Official title:
An Open Label, Multicenter, Single Arm Phase II Study to Evaluate the Activity and Tolerability of the Novel mTOR Inhibitor, MLN0128 (TAK-228), in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Whose Tumors Harbor a TSC1 and/or a TSC2 Mutation
This pilot phase II trial studies how well sapanisertib works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1 and/or TSC2 mutations (changes in deoxyribonucleic acid [DNA]).Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the overall response rate (ORR) defined as complete response (CR) and
partial response (PR) in patients with locally advanced or metastatic transitional cell
carcinoma (TCC) harboring a TSC1 mutation.
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of sapanisertib (MLN0128) (TAK-228) in patients
with locally advanced or metastatic TCC harboring a TSC1 mutation.
II. To evaluate progression free survival (PFS) and overall survival (OS).
TERTIARY OBJECTIVES:
I. To determine the ORR in patients with locally advanced or metastatic TCC harboring a TSC2
mutation.
II. To evaluate toxicity, PFS, and OS in TSC2 mutation patients.
OUTLINE:
Patients receive sapanisertib orally (PO) once daily (QD) on days 1-28. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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