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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: Completed Phase 2 study of Bladder Cancer and Carcinoma in Situ, sponsored by Endo Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 1993-11 |
| Est. Completion | 1997-04 |
| Phase | Phase 2 |
What the finished NCT01316874 record still lists
NCT01316874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
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Where NCT01316874's enrollment target sits among peer trials
90 90th of 175 higher than 86 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.
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