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NCT00412581 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00412581: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00412581 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412581, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Primary Objectives: 1\. To determine the maximum tolerated dose (MTD) of intravenous DTIC during the first 2 cycles (6 weeks) of treatment when administered in combination with a fixed dose of oral Lenalidomide in patients with metastatic malignant melanoma previously untreated with systemic chemotherapy. Secondary Objectives: 1. To define the recommended Phase II doses of Lenalidomide and DTIC when administered as combination therapy. 2. To evaluate the safety and toxicity profile of combination Lenalidomide plus DTIC. 3. To evaluate the preliminary efficacy of combination Lenalidomide plus DTIC.
Interventions
- DRUG Lenalidomide
- DRUG Dacarbazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
What the finished NCT00412581 record still lists
NCT00412581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Lenalidomide is the first listed.
NCT00412581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00412581 about?
NCT00412581 is a clinical study titled "Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma". Primary Objectives: 1\. To determine the maximum tolerated dose (MTD) of intravenous DTIC during the first 2 cycles (6 weeks) of treatment when administered in combination with a fixed dose of oral Lenalidomide in patients with metastatic malignant melanoma previously untreated with systemic chemot...
What is the current status of trial NCT00412581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2005-09. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00412581?
The interventions under investigation include: Lenalidomide (DRUG), Dacarbazine (DRUG).
Who is sponsoring clinical trial NCT00412581?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00412581's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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