Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
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
Sponsor: National Cancer Institute (NCI)
Listed as NCT03047213, this observational or N/A phase trial focuses on Locally Advanced Bladder Urothelial Carcinoma and Metastatic Transitional Cell Carcinoma and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 44 times since 2017, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)PRIMARY OBJECTIVE:
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 or TSC2 mutation.
II. To evaluate progression free survival (PFS) and overall survival (OS).
EXPLORATORY 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. Cycles 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 and every 6 months thereafter.
PRIMARY OBJECTIVE:
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 or TSC2 mutation.
II. To evaluate progression free survival (PFS) and overall survival (OS).
EXPLORATORY 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. Cycles 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 and every 6 months thereafter.
Status Flow
Change History
44 versions recorded-
Apr 13, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE2 → None
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Mar 2026 — Present [monthly]
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Jan 2026 — Present [monthly]
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▶ Show 39 earlier versions
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Mar 2025 — Jun 2025 [monthly]
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Status: Suspended → Active Not Recruiting
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Oct 2020 — Nov 2020 [monthly]
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Feb 2017 — Apr 2017 [monthly]
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First recorded
Eligibility Summary
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.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .