Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT01316874 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01316874 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01316874?
The interventions under investigation include: Valrubicin, 800 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01316874?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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