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NCT01127451 · ClinicalTrials.gov registry record · Phase 2
Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma
A Phase 2 study of Stage IV Melanoma and Stage IIIC Melanoma, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 10
- Study locations
NCT01127451: Completed Phase 2 study of Stage IV Melanoma and Stage IIIC Melanoma, sponsored by Eisai.
NCT01127451 is a Phase 2 study of Stage IV Melanoma and Stage IIIC Melanoma that has completed, run by Eisai. The registered enrollment target is 75 participants, above the 41-participant average among 13 other Stage IV Melanoma trials with a reported enrollment target (83% higher). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01127451, a Phase 2 study of Stage IV Melanoma and Stage IIIC Melanoma, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to determine whether participants with Stage IIIC and Stage IV Melanoma experience benefit when treated with Denileukin diftitox in two different dosing schedules.
Primary Outcome
irORR was defined as the percentage of participants with best confirmed response (immune-related complete response \[irCR\] or immune-related partial response \[irPR\]). irORR was assessed by immune-related response criteria (irRC). Per irRC criteria, irCR was defined as complete disappearance of all tumor lesions, whether measurable or not, and no new lesions. irPR was defined as decrease in tumor burden by 50 percent (%) or greater (confirmed in 2 observations at least 4 weeks apart).
Conditions Studied
Interventions
- DRUG Denileukin diftitox
Study Locations (10)
California
- - Encinitas
- - Los Angeles
District of Columbia
- - Washington D.C.
Illinois
- - Chicago
Kentucky
- - Louisville
Maryland
- - Baltimore
Michigan
- - Detroit
Nebraska
- - Lincoln
Oregon
- - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2010-06-22 |
| Est. Completion | 2015-04-07 |
| Phase | Phase 2 |
What the finished NCT01127451 record still lists
NCT01127451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 41-participant average among 13 other Stage IV Melanoma trials with a reported enrollment target (83% higher).
The record links to 2 conditions, with Stage IV Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Denileukin diftitox is the first listed.
NCT01127451 lists 10 locations in 9 states (California, District of Columbia, Illinois).
Frequently Asked Questions
What is clinical trial NCT01127451 about?
NCT01127451 is a clinical study titled "Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma". The purpose of this study is to determine whether participants with Stage IIIC and Stage IV Melanoma experience benefit when treated with Denileukin diftitox in two different dosing schedules.
What is the current status of trial NCT01127451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2010-06-22. Estimated completion is 2015-04-07.
What conditions does trial NCT01127451 study?
This clinical trial studies the following conditions: Stage IV Melanoma, Stage IIIC Melanoma.
What interventions are being tested in trial NCT01127451?
The interventions under investigation include: Denileukin diftitox (DRUG).
Who is sponsoring clinical trial NCT01127451?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01127451 being conducted?
This trial has 10 study locations across California, District of Columbia, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV 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 NCT01127451's enrollment target sits among peer trials
75 2nd of 13 the highest of 13 other Stage IV Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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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