Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations (NCT03047213)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Los Angeles General Medical Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Keck Medical Center of USC Pasadena — Pasadena, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut
- Yale University — New Haven, Connecticut
- Northwestern University — Chicago, Illinois
- University of Kansas Clinical Research Center — Fairway, Kansas
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
- Nebraska Medicine-Bellevue — Bellevue, Nebraska
- Nebraska Medicine-Village Pointe — Omaha, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Vanderbilt Breast Center at One Hundred Oaks — Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Locally Advanced Bladder Urothelial Carcinoma
- Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy — Anchorage, Alaska
- ARID1A and/or KDM6A Mutation and CXCL13 Expression — Houston, Texas
- Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer — Birmingham, Alabama
- Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy — Los Angeles, California
- Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma — Atlanta, Georgia
Explore by condition: All Locally Advanced Bladder Urothelial Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.