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Active, not recruiting Phase 2 Interventional Results available

Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations

ClinicalTrials.gov ID: NCT03047213

Public ClinicalTrials.gov record NCT03047213. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 3:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03047213
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
17 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 24, 2017 (Actual)
Primary completion
Oct 6, 2020 (Actual)
Completion
Nov 12, 2026 (Estimated)
Last update posted
Jul 31, 2026

2017 – 2026

United States locations

U.S. sites
20
U.S. states
12
U.S. cities
15
Facility City State ZIP Site status
Los Angeles General Medical Center Los Angeles California 90033 —
USC / Norris Comprehensive Cancer Center Los Angeles California 90033 —
Keck Medical Center of USC Pasadena Pasadena California 91105 —
University of California Davis Comprehensive Cancer Center Sacramento California 95817 —
Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut 06510 —
Yale University New Haven Connecticut 06520 —
Northwestern University Chicago Illinois 60611 —
University of Kansas Clinical Research Center Fairway Kansas 66205 —
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
University of Michigan Rogel Cancer Center Ann Arbor Michigan 48109 —
Nebraska Medicine-Bellevue Bellevue Nebraska 68123 —
Nebraska Medicine-Village Pointe Omaha Nebraska 68118 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina 27599 —
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 —
Vanderbilt Breast Center at One Hundred Oaks Nashville Tennessee 37204 —
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232 —
Huntsman Cancer Institute/University of Utah Salt Lake City Utah 84112 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03047213, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03047213 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →