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NCT00679289 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma

A Phase 2 study of Metastatic Melanoma and Cutaneous Melanoma, sponsored by Ludwig Institute for Cancer Research.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target
2
Study locations

NCT00679289 is a Phase 2 study of Metastatic Melanoma and Cutaneous Melanoma that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 36 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (57% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00679289, a Phase 2 study of Metastatic Melanoma and Cutaneous Melanoma, has completed, sponsored by Ludwig Institute for Cancer Research.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target
2
Study locations

Study Summary

This was a Phase 2, open-label study of KW2871 (ecromeximab) in combination with high-dose interferon-α2b (HDI) in patients with metastatic melanoma. The primary objectives of this study were to assess progression-free survival (PFS) and safety. The secondary objectives were to assess the objective response rate, KW2871 pharmacokinetics (PK), and other exploratory immunology as indicated (e.g., development of human anti-chimeric antibodies \[HACA\], activity of antibody-dependent cell-mediated cytotoxicity \[ADCC\] and complement-dependent cytotoxicity \[CDC\] in peripheral blood, number and functional state of tumor-infiltrating immune cells and expression of GD3 in immune and tumor cells of tumor biopsies, and markers of interferon \[IFN\] response/resistance and markers of resistance to ADCC/CDC in peripheral blood mononuclear cells \[PBMCs\]).

Interventions

  • DRUG HDI
  • DRUG KW2871

Study Locations (2)

Illinois

  • University of Chicago Hospital - Chicago

Pennsylvania

  • University of Pittsburgh Cancer Institute - Pittsburgh

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2008-03-28
Est. Completion 2014-02-03
Phase Phase 2

What the Registry Record Tells You About NCT00679289

The ClinicalTrials.gov registry entry for NCT00679289 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (57% lower). The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which HDI is the first listed.

NCT00679289 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00679289 about?

NCT00679289 is a clinical study titled "Phase II Study of KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma". This was a Phase 2, open-label study of KW2871 (ecromeximab) in combination with high-dose interferon-α2b (HDI) in patients with metastatic melanoma. The primary objectives of this study were to assess progression-free survival (PFS) and safety. The secondary objectives were to assess the objective ...

What is the current status of trial NCT00679289?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2008-03-28. Estimated completion is 2014-02-03.

What conditions does trial NCT00679289 study?

This clinical trial studies the following conditions: Metastatic Melanoma, Cutaneous Melanoma.

What interventions are being tested in trial NCT00679289?

The interventions under investigation include: HDI (DRUG), KW2871 (DRUG).

Who is sponsoring clinical trial NCT00679289?

This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00679289 being conducted?

This trial has 2 study locations across Illinois, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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