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NCT00246012 · ClinicalTrials.gov registry record · Phase 1
A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma
A Phase 1 study of Melanoma, sponsored by Centocor.
- Completed
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
- 20
- Study locations
NCT00246012: Completed Phase 1 study of Melanoma, sponsored by Centocor.
NCT00246012 is a Phase 1 study of Melanoma that has completed, run by Centocor. The registered enrollment target is 144 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00246012, a Phase 1 study of Melanoma, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the intetumumab, alone and in combination with dacarbazine, in patients with stage 4 melanoma.
Primary Outcome
The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dacarbazine
- DRUG Intetumumab
Study Locations (20)
California
- - La Jolla
- - Santa Monica
- - Walnut Creek
Other
- - Berlin
- - Bonn
- - Buxtehude
New York
- - Buffalo
- - New York
Arizona
- - Scottsdale
Colorado
- - Aurora
District of Columbia
- - Washington D.C.
Florida
- - Miami
Georgia
- - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-02 |
| Phase | Phase 1 |
What the finished NCT00246012 record still lists
NCT00246012 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00246012 names 20 study sites across 15 states, led by California, Other, New York.
Frequently Asked Questions
What is clinical trial NCT00246012 about?
NCT00246012 is a clinical study titled "A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma". The purpose of this study is to evaluate the safety and effectiveness of the intetumumab, alone and in combination with dacarbazine, in patients with stage 4 melanoma.
What is the current status of trial NCT00246012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2005-05. Estimated completion is 2009-02.
What conditions does trial NCT00246012 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT00246012?
The interventions under investigation include: Placebo (DRUG), Dacarbazine (DRUG), Intetumumab (DRUG).
Who is sponsoring clinical trial NCT00246012?
This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00246012 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00246012's enrollment target sits among peer trials
144 91st of 266 higher than 176 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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