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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00412581
The ClinicalTrials.gov registry entry for NCT00412581 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lenalidomide is the first listed.
NCT00412581 reports 0 study locations.
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.
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