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NCT01259063 · ClinicalTrials.gov registry record · Phase 1
RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01259063: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01259063 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01259063, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to study the effects of these two drugs together. The investigators want to find out what effects, good and/or bad, this treatment has on the patient and the cancer.
Primary Outcome
Everolimus (mg) given in conjunction with intravesical gemcitabine
Interventions
- DRUG Everolimus and Intravesical Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2010-12 |
| Est. Completion | 2017-06 |
| Phase | Phase 1 |
What the finished NCT01259063 record still lists
NCT01259063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Everolimus and Intravesical Gemcitabine is the first listed.
NCT01259063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01259063 about?
NCT01259063 is a clinical study titled "RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder". The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II p...
What is the current status of trial NCT01259063?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2010-12. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01259063?
The interventions under investigation include: Everolimus and Intravesical Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01259063?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01259063's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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