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NCT03047213 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
17
Enrollment target
20
Study locations

NCT03047213 is a Phase 2 study of Metastatic Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT03047213, a Phase 2 study of Metastatic Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
17 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Metastatic Urothelial Carcinoma Locally Advanced Bladder Urothelial Carcinoma Stage IV Bladder Urothelial Carcinoma AJCC v7 Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Recurrent Bladder Carcinoma Metastatic Transitional Cell Carcinoma

Interventions

  • DRUG Sapanisertib

Study Locations (20)

California

  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • Keck Medical Center of USC Pasadena - Pasadena
  • University of California Davis Comprehensive Cancer Center - Sacramento

Nebraska

  • Nebraska Medicine-Bellevue - Bellevue
  • Nebraska Medicine-Village Pointe - Omaha
  • University of Nebraska Medical Center - Omaha

Connecticut

  • Smilow Cancer Center/Yale-New Haven Hospital - New Haven
  • Yale University - New Haven

Massachusetts

  • Brigham and Women's Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Tennessee

  • Vanderbilt Breast Center at One Hundred Oaks - Nashville
  • Vanderbilt University/Ingram Cancer Center - Nashville

Illinois

  • Northwestern University - Chicago

Kansas

  • University of Kansas Clinical Research Center - Fairway

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2017-08-24
Est. Completion 2026-11-12
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT03047213

The ClinicalTrials.gov registry entry for NCT03047213 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (87% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Sapanisertib is the first listed.

NCT03047213 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Nebraska, Connecticut.

Frequently Asked Questions

What is clinical trial NCT03047213 about?

NCT03047213 is a clinical study titled "Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations". 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 de...

What is the current status of trial NCT03047213?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2017-08-24. Estimated completion is 2026-11-12.

What conditions does trial NCT03047213 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma AJCC v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Recurrent Bladder Carcinoma.

What interventions are being tested in trial NCT03047213?

The interventions under investigation include: Sapanisertib (DRUG).

Who is sponsoring clinical trial NCT03047213?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03047213 being conducted?

This trial has 20 study locations across California, Connecticut, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.