Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
NCT03047213 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-08-24 |
| Est. Completion | 2026-11-12 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03047213
The ClinicalTrials.gov registry entry for NCT03047213 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03047213 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Nebraska, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03047213?
The interventions under investigation include: Sapanisertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03047213?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.