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COMPLETED Phase 2

Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma

NCT01127451 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 75 participants
Start Date 2010-06-22
Est. Completion 2015-04-07
Phase Phase 2

Sponsor

Eisai

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01127451

The ClinicalTrials.gov registry entry for NCT01127451 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01127451 reports 10 study locations spanning 9 distinct geographic areas — top geographies include California, District of Columbia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01127451?

The interventions under investigation include: Denileukin diftitox (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01127451?

This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial