Trial · NCT01310803
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
NCT01310803, Phase 3, Terminated, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2014-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT01310803. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01310803
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT01310803
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Carcinoma in Situ, Transitional Cell Carcinoma, Non-muscle Invasive Bladder Cancer
- Interventions
- VALSTAR - Maintenance Therapy, No Maintenance treatment ( Standard of Care)
- First posted
- 2011-03-09
- Last updated
- 2017-10-05
- Results first posted
- 2014-10-22
- Limitations and caveats
- This study was terminated early. Only one subject was enrolled. No study results were generated.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder. | 2 years | 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). |
| Secondary | To Evaluate the Safety and Tolerability of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder | 2 years | The occurrence of serious adverse events (SAEs), occurrence of local adverse reactions (LARs), results of vital signs, physical exams and laboratory test, and study discontinuation due to inability to complete valrubicin instillations |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder. | 2 years | No analysis completed due to limited enrollment (1 subject) prior to study termination. | ||
| SECONDARY | To Evaluate the Safety and Tolerability of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder | 2 years | No analysis completed due to limited enrollment (1 subject) prior to study termination. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Maintenance Therapy | 1 | |
| Overall Study | STARTED | No Maintenance (Standard of Care) | 0 | |
| Overall Study | COMPLETED | Maintenance Therapy | 0 | |
| Overall Study | COMPLETED | No Maintenance (Standard of Care) | 0 | |
| Overall Study | NOT COMPLETED | Maintenance Therapy | 1 | |
| Overall Study | NOT COMPLETED | No Maintenance (Standard of Care) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maintenance Therapy | ||
| Total, all-cause mortality | No Maintenance (Standard of Care) | ||
| Total, other adverse events | Maintenance Therapy | 0 | 1 |
| Total, other adverse events | No Maintenance (Standard of Care) | 0 | 0 |
| Total, serious adverse events | Maintenance Therapy | 0 | 1 |
| Total, serious adverse events | No Maintenance (Standard of Care) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01310803
GET https://conductscience.org/api/trials/v1/NCT01310803/registered