CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 17 enrolled
Drug / intervention
Sapanisertibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03047213
NCT03047213Phase 2Active
CompareCT.gov

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

National Cancer Institute (NCI)·interventional·Posted Feb 8, 2017·Updated May 13, 2026

In Brief

A Phase 2 clinical trial evaluating Sapanisertib for Locally Advanced Bladder Urothelial Carcinoma and 5 related conditions. Active but no longer recruiting, targeting 17 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced Bladder Urothelial Carcinoma, Metastatic Transitional Cell Carcinoma, Metastatic Urothelial Carcinoma, Recurrent Bladder Carcinoma, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
20172018201920202021202220232024202520262027
First PostedFeb 8, 2017
Enrollment StartAug 24, 2017
Primary CompletionOct 6, 2020
Study CompletionNov 12, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.4 years ago

Interventions

Sapanisertibdrug

Given PO