Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00654186 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients
A Phase 2 study, sponsored by Oncology Specialists, S.C..
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT00654186: Completed Phase 2 study, sponsored by Oncology Specialists, S.C..
NCT00654186 is a Phase 2 study that has completed, run by Oncology Specialists, S.C.. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00654186, a Phase 2 study, has completed, sponsored by Oncology Specialists, S.C..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Revlimid® 25 mg daily on Days 1-21 followed by 7 days of rest repeated every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion.
Primary Outcome
The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as \> or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined \< a 30% decrease in the sum of the longest diameter of measureable lesions and \< a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions. Prostate-Specific Antigen (PSA) was also evaluated.
Interventions
- DRUG Revlimid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT00654186 record still lists
NCT00654186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which Revlimid is the first listed.
NCT00654186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00654186 about?
NCT00654186 is a clinical study titled "Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients". This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Revlimid® 25 mg daily on Days 1-21 followed by 7 days of rest repeated every 28 days. Treatment continues until disease progression, patient's w...
What is the current status of trial NCT00654186?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2008-02. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00654186?
The interventions under investigation include: Revlimid (DRUG).
Who is sponsoring clinical trial NCT00654186?
This trial is sponsored by Oncology Specialists, S.C., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00654186's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02445781 · 32 participants · Early Phase 1
Differing Levels of Hypoglycemia
- NCT02792270 · 32 participants · NA
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- NCT03068910 · 32 participants · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- NCT03208868 · 32 participants · NA
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia