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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00066196 |
The primary objectives of this study are:
Condition | Intervention | Phase |
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Melanoma Malignant Metastatic Melanoma |
Biological: MEDI--522 Biological: Integrin + Dacarbazine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase II, Randomized, Open-Label Study Evaluating The Antitumor Activity Of MEDI-522, A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin, ± Dacarbazine In Patients With Metastatic Melanoma |
Estimated Enrollment: | 110 |
Study Start Date: | August 2003 |
Study Completion Date: | June 2007 |
Estimated Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2
Integrin + Dacarbazine
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Biological: Integrin + Dacarbazine
supplied in other formulations
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1: Active Comparator
MEDI-522
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Biological: MEDI--522
IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.
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This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI 522 ± DTIC in previously untreated (other than adjuvant immunotherapy) patients with Stage IV metastatic melanoma (AJCC staging).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion
Patients must meet all of the following criteria at the time of randomization:
Exclusion
Patients must have none of the following at the time of randomization:
Study Director: | Luz Hammershaimb, M.D. | MedImmune LLC |
Responsible Party: | MedImmune Inc. ( Luz Hammershaimb, M.D., V.P., Clinical Dev. ) |
Study ID Numbers: | MI-CP095 |
Study First Received: | August 5, 2003 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00066196 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dacarbazine Melanoma Neuroendocrine Tumors Antibodies, Monoclonal Neuroectodermal Tumors Antibodies Neoplasms, Germ Cell and Embryonal |
Nevus, Pigmented Neuroepithelioma Nevus Antineoplastic Agents, Alkylating Alkylating Agents Immunoglobulins |
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 |