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NCT01373294 · ClinicalTrials.gov registry record · Phase 2
Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer
A Phase 2 study of Bladder Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01373294: Completed Phase 2 study of Bladder Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01373294 is a Phase 2 study of Bladder Cancer that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 17 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01373294, a Phase 2 study of Bladder Cancer, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The purposes of this study are to: * find out whether participants' cancer returns or gets worse while they are taking lenalidomide and Bacille Calmette-Guerrin (BCG); * evaluate the safety and tolerability of the combination of lenalidomide and BCG; * compare the cancer progression of participants taking lenalidomide and BCG versus participants taking only BCG
Primary Outcome
The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too f
Conditions Studied
Interventions
- DRUG Lenalidomide
- DRUG Bacille Calmette-Guerrin (BCG)
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-11-30 |
| Est. Completion | 2018-12-10 |
| Phase | Phase 2 |
What the finished NCT01373294 record still lists
NCT01373294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Lenalidomide is the first listed.
NCT01373294 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01373294 about?
NCT01373294 is a clinical study titled "Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer". The purposes of this study are to: * find out whether participants' cancer returns or gets worse while they are taking lenalidomide and Bacille Calmette-Guerrin (BCG); * evaluate the safety and tolerability of the combination of lenalidomide and BCG; * compare the cancer progression of participants...
What is the current status of trial NCT01373294?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2011-11-30. Estimated completion is 2018-12-10.
What conditions does trial NCT01373294 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT01373294?
The interventions under investigation include: Lenalidomide (DRUG), Bacille Calmette-Guerrin (BCG) (DRUG).
Who is sponsoring clinical trial NCT01373294?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01373294 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01373294's enrollment target sits among peer trials
17 159th of 175 higher than 17 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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