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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00533702 |
The primary objective of this study is to determine the progression-free survival (PFS) of patients with previously untreated metastatic malignant melanoma when treated with IMC 1121B alone or in combination with dacarbazine.
Condition | Intervention | Phase |
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Metastatic Malignant Melanoma |
Drug: IMC-1121 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma |
Estimated Enrollment: | 104 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
IMC-1121B
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2: Active Comparator
IMC-1121 + dacarbazine
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Drug: IMC-1121
IMC-1121B injectable solution in single-use, 50 mL vials containing 250 mg (5.0 mg/mL) of product, administered as an i.v. infusion at 10 mg/kg every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria. Dacarbazine 1000 mg/m2 administered as an i.v. infusion once every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria. |
The purpose of this study is to determine the antitumor activity, safety profile,pharmacodynamic activity, and pharmacokinetics of IMC-1121B when used as monotherapy or in combination with dacarbazine in patients with metastatic malignant melanoma who have not received prior systemic therapy for this disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
United States, Alabama | |
Clearview Cancer Institute | |
Huntsville, Alabama, United States, 35805 | |
United States, Arizona | |
Premiere Oncology of Arizona | |
Scottsdale, Arizona, United States, 85260 | |
Scottsdale Medical Specialists | |
Scottsdale, Arizona, United States, 85258 | |
United States, California | |
Cancer Care Associates of Fresno Medical Group, Inc. | |
Fresno, California, United States, 93720 | |
St Mary's Medical Center | |
San Francisco, California, United States, 94117 | |
United States, Colorado | |
Anschutz Cancer Pavillion | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
MD Anderson Cancer Center Orlando | |
Orlando, Florida, United States, 32806 | |
Integrated Community Oncology Network | |
Jacksonville, Florida, United States, 32256 | |
United States, Mississippi | |
The Jones Clinic, PC | |
Oxford, Mississippi, United States, 38655 | |
United States, Montana | |
Montana Cancer Specialists | |
Missoula, Montana, United States, 59806 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 | |
NYU Clinical Cancer Center | |
New York City, New York, United States, 10016 | |
United States, Pennsylvania | |
Abington Hematology Oncology Associates | |
Willow Grove, Pennsylvania, United States, 19090 | |
United States, Texas | |
Center for Oncology Research and Treatment | |
Dallas, Texas, United States, 75230 | |
Agop Bedikian, MD | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109 |
Study Director: | Jonathan Schwartz, MD | ImClone Systems |
Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP12-0604 |
Study First Received: | September 17, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00533702 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Phase II Melanoma IMC-1121B ImClone |
Neuroectodermal Tumors Dacarbazine Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Antineoplastic Agents, Alkylating Nevus Alkylating Agents Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Dacarbazine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Pharmacologic Actions Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |