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NCT01310803 · ClinicalTrials.gov registry record · Phase 3
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT01310803: Clinical Trial Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT01310803 is a Phase 3 study that was terminated before completion, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01310803, a Phase 3 study, was terminated before completion, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin as compared to induction with valrubicin only in subjects with CIS of the bladder. The randomization will be 1:1 and subjects will be stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last bacillus Calmette-Guerin (BCG) failure (\>1 year vs. \<1 year).
Primary Outcome
time interval from randomization to an event. An event is defined as tumor recurrence (any stage or grade), tumor progression to muscle-invasive bladder cancer (MIBC), metastatic bladder cancer or death from any cause, whichever occurs first. Tumor recurrence or progression must be documented by biopsy/transurethral resection of bladder tumor (TURBT).
Interventions
- DRUG VALSTAR - Maintenance Therapy
- OTHER No Maintenance treatment ( Standard of Care)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
Why NCT01310803 stopped before completion
NCT01310803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which VALSTAR - Maintenance Therapy is the first listed.
NCT01310803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01310803 about?
NCT01310803 is a clinical study titled "Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder". This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin as compared to induction with valrubicin only in subjects with CIS of t...
What is the current status of trial NCT01310803?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2011-05. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01310803?
The interventions under investigation include: VALSTAR - Maintenance Therapy (DRUG), No Maintenance treatment ( Standard of Care) (OTHER).
Who is sponsoring clinical trial NCT01310803?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01310803's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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