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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: Active Phase 2 study of Metastatic Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall Response Rate is the proportion of the patients with either complete response (CR) or partial response (PR) by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target lesions and partial response (PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response Rate is the proportion of the patients with either comple
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 |
What the registry record for NCT03047213 still lists
NCT03047213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (87% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Where NCT03047213's enrollment target sits among peer trials
17 27th of 30 higher than 4 of 30 other Metastatic Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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