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NCT01378091 · ClinicalTrials.gov registry record · Phase 1
Study of Lenalidomide and Docetaxel in Subjects With Androgen Independent Prostate Cancer
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT01378091: Completed Phase 1 study, sponsored by Columbia University.
NCT01378091 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378091, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
Primary objectives: To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given every three weeks and prednisone, as combination therapy to subjects with androgen independent prostate cancer To evaluate the safety profile of the combination of daily lenalidomide and every three week docetaxel and prednisone when given to subjects with androgen independent prostate cancer Secondary objective: To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week docetaxel and prednisone when given to subjects with androgen independent prostate cancer.
Primary Outcome
The MTDs of lenalidomide, docetaxel and prednisone when given as combination therapy will be defined as the highest dose level at which no more than 1 out of 6 subjects experiences Dose Limiting Toxicity (DLT).
Interventions
- DRUG Docetaxel
- DRUG Lenalidomide
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2005-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01378091 record still lists
NCT01378091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT01378091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378091 about?
NCT01378091 is a clinical study titled "Study of Lenalidomide and Docetaxel in Subjects With Androgen Independent Prostate Cancer". Primary objectives: To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given every three weeks and prednisone, as combination therapy to subjects with androgen independent prostate cancer To evaluate the safety profile of the combination of daily lenalidomide and e...
What is the current status of trial NCT01378091?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2005-08. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01378091?
The interventions under investigation include: Docetaxel (DRUG), Lenalidomide (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT01378091?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01378091's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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