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NCT00412828 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
A Phase 1 study of Unresectable Stage III or Stage IV Melanoma, sponsored by CuraGen Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
- 4
- Study locations
NCT00412828: Completed Phase 1 study of Unresectable Stage III or Stage IV Melanoma, sponsored by CuraGen Corporation.
NCT00412828 is a Phase 1 study of Unresectable Stage III or Stage IV Melanoma that has completed, run by CuraGen Corporation. The registered enrollment target is 117 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412828, a Phase 1 study of Unresectable Stage III or Stage IV Melanoma, has completed, sponsored by CuraGen Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.
Conditions Studied
Interventions
- DRUG CR011-vcMMAE
Study Locations (4)
California
- Angeles Clinic and Research Institute - Santa Monica
Connecticut
- Yale University - New Haven
New York
- New York University Medical Center - New York
Texas
- M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2006-06 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
What the finished NCT00412828 record still lists
NCT00412828 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% higher).
The record links to 1 condition, with Unresectable Stage III or Stage IV Melanoma appearing as the primary indexed condition, and to 1 intervention - of which CR011-vcMMAE is the first listed.
NCT00412828 reports a single indexed study location in California, Connecticut, New York.
Frequently Asked Questions
What is clinical trial NCT00412828 about?
NCT00412828 is a clinical study titled "A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma". This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalatin...
What is the current status of trial NCT00412828?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2006-06. Estimated completion is 2011-05.
What conditions does trial NCT00412828 study?
This clinical trial studies the following conditions: Unresectable Stage III or Stage IV Melanoma.
What interventions are being tested in trial NCT00412828?
The interventions under investigation include: CR011-vcMMAE (DRUG).
Who is sponsoring clinical trial NCT00412828?
This trial is sponsored by CuraGen Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00412828 being conducted?
This trial has 4 study locations across California, Connecticut, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00412828's enrollment target sits among peer trials
117 499th of 2000 higher than 1,500 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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