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NCT04386746 · ClinicalTrials.gov registry record · Phase 2

Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer

A Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Active
Registry status
Phase 2
Development phase
27
Enrollment target
1
Study location

NCT04386746: Active Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT04386746 is a Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 27 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04386746, a Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
27 participants
Enrollment target
1
Study location

Study Summary

A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).

Primary Outcome

Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology.

Interventions

  • DRUG Docetaxel
  • DRUG Gemcitabine

Study Locations (1)

Maryland

  • Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2020-07-29
Est. Completion 2026-11-30
Phase Phase 2

What the registry record for NCT04386746 still lists

NCT04386746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel is the first listed.

NCT04386746 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT04386746 about?

NCT04386746 is a clinical study titled "Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer". A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).

What is the current status of trial NCT04386746?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2020-07-29. Estimated completion is 2026-11-30.

What conditions does trial NCT04386746 study?

This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma Bladder.

What interventions are being tested in trial NCT04386746?

The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT04386746?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04386746 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Bladder Cancer

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 NCT04386746's enrollment target sits among peer trials

27 141st of 175 higher than 33 of 175 other Bladder Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bladder Cancer 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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Source: ClinicalTrials.gov NCT04386746, the US trial registry maintained by the National Library of Medicine. NCT04386746 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.