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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: Completed Phase 2 study of Metastatic Melanoma and Cutaneous Melanoma, sponsored by Ludwig Institute for Cancer Research.
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. According to ClinicalTrials.gov, the official US trial registry.
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 \[PBMCs\]).
Primary Outcome
PFS was calculated from the date of the first infusion to the date of documented progression or death, whichever occurred first. PFS analyses were performed using Kaplan-Meier methods for all patients combined and for patients in Cohort 3. Based on published results from Phase 3 randomized clinical trials in patients with metastatic melanoma at the time of study initiation, 2.5 months was estimated as a conservative (i.e., somewhat high) external standard of median PFS. The intent of this study
Conditions Studied
Interventions
- DRUG HDI
- DRUG KW2871
Study Locations (2)
Illinois
- University of Chicago Hospital - Chicago
Pennsylvania
- University of Pittsburgh Cancer Institute - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-03-28 |
| Est. Completion | 2014-02-03 |
| Phase | Phase 2 |
What the finished NCT00679289 record still lists
NCT00679289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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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Where NCT00679289's enrollment target sits among peer trials
36 47th of 91 higher than 43 of 91 other Metastatic Melanoma trials
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