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NCT04179162 · ClinicalTrials.gov registry record · Phase 1
Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment
A Phase 1 study of Non-muscle Invasive Bladder Cancer (NMIBC), sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 8
- Study locations
NCT04179162: Active Phase 1 study of Non-muscle Invasive Bladder Cancer (NMIBC), sponsored by Memorial Sloan Kettering Cancer Center.
NCT04179162 is a Phase 1 study of Non-muscle Invasive Bladder Cancer (NMIBC) that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04179162, a Phase 1 study of Non-muscle Invasive Bladder Cancer (NMIBC), is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study will test the safety of BCG and gemcitabine in people who have BCG-relapsing Non-Muscle Invasive Bladder Cancer (NMIBC). The researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with BCG. The study will also look at whether this combination of drugs is effective in treating BCG-relapsing NMIBC.
Primary Outcome
Describe the toxicities by frequency and by grade.This study will use CTCAE version 5.0 for toxicity and serious adverse event reporting.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Bacillus Calmette-Guérin (BCG)
Study Locations (8)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Connecticut
- Hartford Healthcare (Data Collection) - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2019-11-22 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What the registry record for NCT04179162 still lists
NCT04179162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Non-muscle Invasive Bladder Cancer (NMIBC) appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT04179162 lists 8 locations in 3 states (New York, New Jersey, Connecticut).
Frequently Asked Questions
What is clinical trial NCT04179162 about?
NCT04179162 is a clinical study titled "Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment". This study will test the safety of BCG and gemcitabine in people who have BCG-relapsing Non-Muscle Invasive Bladder Cancer (NMIBC). The researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with BCG. The study will also look...
What is the current status of trial NCT04179162?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2019-11-22. Estimated completion is 2026-11.
What conditions does trial NCT04179162 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer (NMIBC).
What interventions are being tested in trial NCT04179162?
The interventions under investigation include: Gemcitabine (DRUG), Bacillus Calmette-Guérin (BCG) (DRUG).
Who is sponsoring clinical trial NCT04179162?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04179162 being conducted?
This trial has 8 study locations across Connecticut, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-muscle Invasive Bladder Cancer (NMIBC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04179162's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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