Study of TPI 287 Administered Every 21 Days 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 1 study evaluating the intravenous administration of TPI 287 on an every 21 day cycle.
Drug: TPI 287 Injection
Cortice Biosciences, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies|
- To determine the maximum tolerated dose of TPI 287 administered every 21 days
- To determine the safety of TPI 287
- To determine the antitumor activity of TPI 287
- To determine the pharmacokinetic profile of TPI 287
|Study Start Date:||November 2005|
|Study Completion Date:||February 2007|
The primary objective of this study is to determine the maximum tolerated dose of TPI 287 administered every 21 days for Phase II clinical trials.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256191
|United States, Colorado|
|Rocky Mountain Cancer Center|
|Denver, Colorado, United States, 80218|
|Study Director:||Sandra Silberman, MD||Tapestry Pharmaceuticals, Inc.|