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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00569153 |
The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.
Condition | Intervention | Phase |
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Prostatic Neoplasms |
Drug: TAK-700 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects |
Estimated Enrollment: | 61 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: TAK-700
TAK-700 100 mg, 200 mg, 300 mg, 400 mg and 600mg (dose escalation), tablets, orally, twice daily until disease progression or occurrence of an unacceptable adverse event.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center | 1-866-835-2233 | medical@mlnm.com |
United States, California | |
Cedars-Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048 | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Northwestern University Medical Center | Recruiting |
Chicago, Illinois, United States, 60611 | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 |
Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Research Monitor ) |
Study ID Numbers: | TAK-700_201, TAK-700-201 |
Study First Received: | December 4, 2007 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00569153 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Androgen-independent prostate cancer, metastatic |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |