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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01310803
The ClinicalTrials.gov registry entry for NCT01310803 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which VALSTAR - Maintenance Therapy is the first listed.
NCT01310803 reports 0 study locations.
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.
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