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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00070837 |
The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up, broken down and eliminated by the body.
Condition | Intervention | Phase |
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Prostatic Neoplasms |
Drug: MLN2704 (DM1 conjugated monoclonal antibody MLN591) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen-Independent Prostate Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Progressive prostate cancer as defined by the presence of one or more of the following despite castrate levels of testosterone (testosterone <50 ng/dL):
Exclusion criteria:
United States, New York | |
Weill Medical College of Cornell University/ New York Presbyterian Hospital | |
New York, New York, United States, 10021 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Duke University Medical Center, Box 3532 | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cleveland Clinic, Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Study ID Numbers: | M59102-051 |
Study First Received: | October 8, 2003 |
Last Updated: | July 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00070837 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Genital Neoplasms, Male Prostatic Diseases Immunologic Factors Urogenital Neoplasms Genital Diseases, Male Antibodies, Monoclonal Antibodies |
Myotonic Dystrophy Prostatic Neoplasms Myotonic Dystrophy 1 Myotonia Atrophica Immunoglobulins Androgens |
Antibodies, Monoclonal Antibodies Neoplasms Neoplasms by Site Immunologic Factors Prostatic Diseases |
Genital Neoplasms, Male Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |