Neoplasms Clinical Trial
Official title:
A Phase I, Open-Label, Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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