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NCT01316874 · ClinicalTrials.gov registry record · Phase 2

Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)

A Phase 2 study of Bladder Cancer and Carcinoma in Situ, sponsored by Endo Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
90
Enrollment target
20
Study locations

NCT01316874 is a Phase 2 study of Bladder Cancer and Carcinoma in Situ that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 90 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT01316874, a Phase 2 study of Bladder Cancer and Carcinoma in Situ, has completed, sponsored by Endo Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
90 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.

Conditions Studied

Bladder Cancer Carcinoma in Situ

Interventions

  • DRUG Valrubicin, 800 mg

Study Locations (20)

California

  • William Friedel, MD - La Mesa
  • Stephen Auerbach, MD - Newport Beach
  • William Moseley, MD - San Diego
  • Standley Brosman, MD - Santa Monica
  • Eugene Dula, MD - Van Nuys

Arizona

  • William Bohnert, MD - Phoenix
  • Scott Swanson, MD - Scottsdale
  • Bruce Dalkin, MD - Tucson
  • Donald Gleason, MD - Tucson

Florida

  • B. Thomas Brown, MD - Daytona Beach
  • Charles Jackson, MD - Fort Lauderdale
  • Marc Soloway, MD - Miami

Illinois

  • Charles Brendler, MD - Chicago
  • Patrick Guinan, MD - Chicago
  • Jeffrey Ignatoff, MD - Evanston

Kentucky

  • David Wood, MD - Lexington
  • John Tuttle, MD - Lexington

Alabama

  • Stacy Childs, MD - Alabaster

Louisiana

  • Dennis Venable, MD - Shreveport

Maryland

  • Harold Frazier, MD - Bethasda

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 1993-11
Est. Completion 1997-04
Phase Phase 2

Sponsor

Endo Pharmaceuticals

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01316874

The ClinicalTrials.gov registry entry for NCT01316874 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Valrubicin, 800 mg is the first listed.

NCT01316874 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT01316874 about?

NCT01316874 is a clinical study titled "Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)". This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.

What is the current status of trial NCT01316874?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 1993-11. Estimated completion is 1997-04.

What conditions does trial NCT01316874 study?

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

What interventions are being tested in trial NCT01316874?

The interventions under investigation include: Valrubicin, 800 mg (DRUG).

Who is sponsoring clinical trial NCT01316874?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01316874 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.