Spots Global Cancer Trial Database for Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
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Trial Identification
Brief Title: Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
Official Title: A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma
Study ID: NCT01335009
Conditions
Interventions
Study Description
Brief 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).
Detailed Description: MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein, which is expressed on cells involved in tumor vasculature. Studies have found endosialin to play a key role in tumor growth and neovessel formation in numerous cancer types including melanoma. Preclinical pharmacological studies have shown that MORAb-004 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the efficacy of MORAb-004 at two dose levels in subjects with metastatic melanoma, as well as to establish serum pharmacokinetics and pharmacodynamics of the antibody.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pinnacle Oncology, Scottsdale, Arizona, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
University of California Los Angeles, Los Angeles, California, United States
University of Colorado Cancer Center, Anschutz Cancer Pavilion, Aurora, Colorado, United States
Yale University, New Haven, Connecticut, United States
The University Of Chicago, Chicago, Illinois, United States
Oncology Specialists, SC, Park Ridge, Illinois, United States
University of Iowa Hospital, Iowa City, Iowa, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Atlantic Health, Morristown, New Jersey, United States
New York University Cancer Institute, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
St. Luke's Hospital & Health Network, Bethlehem, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States
Sydney Cancer Center - Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Newcastle Melanoma Unit, Calvery Mater Newcastle, Waratah, New South Wales, Australia
The Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Universitatsklinikum Essen, Klinik fur Dermatologie, Essen, , Germany
Universitats-Hautklinik, Mainz, , Germany
Eberhard Karls University Tuebingen, Tuebingen, , Germany
The Royal Marsden Hospital, London, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Contact Details
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