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Sponsored by: |
Bristol-Myers Squibb |
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00162136 |
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
Condition | Intervention | Phase |
Solid Malignancies |
Drug: Ixabepilone |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Ixabepilone |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies |
Enrollment: | 71 |
Study Start Date: | September 2005 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A1: Experimental |
Drug: Ixabepilone
Intravenous Infusion, IV, 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |||||
University Of Maryland | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, New Jersey | |||||
The Cancer Institute Of New Jersey | |||||
New Brunswick, New Jersey, United States, 08901 | |||||
United States, Ohio | |||||
Cleveland Clinic Foundation | |||||
Cleveland, Ohio, United States, 44195 |
Bristol-Myers Squibb |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
BMS Clinical Trials Disclosure 
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For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 
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Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA163-085 |
First Received: | September 9, 2005 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00162136 |
Health Authority: | United States: Food and Drug Administration |
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