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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 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. The trial reports 4 study locations across 4 states.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00412828
The ClinicalTrials.gov registry entry for NCT00412828 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CuraGen Corporation, which has 4 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
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