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NCT01335009 · ClinicalTrials.gov registry record · Phase 2
Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
A Phase 2 study of Metastatic Melanoma, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 20
- Study locations
NCT01335009 is a Phase 2 study of Metastatic Melanoma that has completed, run by Eisai. The registered enrollment target is 76 participants, roughly in line with the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target. The trial reports 20 study locations across 13 states.
The verdict
NCT01335009, a Phase 2 study of Metastatic Melanoma, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma. Approximately 80 subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression. Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy. Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability).
Conditions Studied
Interventions
- BIOLOGICAL MORAb-004 (monoclonal antibody)
Study Locations (20)
Pennsylvania
- St. Luke's Hospital & Health Network - Bethlehem
- Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- University of Pittsburgh Cancer Institute - Pittsburgh
California
- The Angeles Clinic and Research Institute - Los Angeles
- University of California Los Angeles - Los Angeles
Illinois
- The University Of Chicago - Chicago
- Oncology Specialists, SC - Park Ridge
New York
- New York University Cancer Institute - New York
- Memorial Sloan-Kettering Cancer Center - New York
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke University Medical Center - Durham
Arizona
- Pinnacle Oncology - Scottsdale
Colorado
- University of Colorado Cancer Center, Anschutz Cancer Pavilion - Aurora
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2011-05-16 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01335009
The ClinicalTrials.gov registry entry for NCT01335009 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 1 intervention - of which MORAb-004 (monoclonal antibody) is the first listed.
NCT01335009 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Pennsylvania, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01335009 about?
NCT01335009 is a clinical study titled "Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma". This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma. Approximately 80 subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. We...
What is the current status of trial NCT01335009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2011-05-16. Estimated completion is 2020-04-10.
What conditions does trial NCT01335009 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT01335009?
The interventions under investigation include: MORAb-004 (monoclonal antibody) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01335009?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01335009 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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