Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, phase I study evaluating the intravenous administration of TPI 287, a novel third generation taxane.
The primary objective of this study is to determine the maximum tolerated dose of TPI 287 for phase II clinical trials. The secondary objectives of the study are: * To determine the safety of TPI 287 * To determine antitumor activity of TPI 287 * To determine the pharmacokinetic profile of TPI 287 * To determine the pharmacodynamic profile of TPI 287
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Arizona Clinical Research Center
Tucson, Arizona, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Georgetown University Medical Center/Lombardi Cancer Center
Washington D.C., District of Columbia, United States
New York Medical College
Valhalla, New York, United States
To determine the maximum tolerated dose of TPI 287
To determine the safety of TPI 287
To determine the antitumor activity of TPI 287
To determine the pharmacokinetic profile of TPI 287
To determine the pharmacodynamic profile of TPI 287
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