NCT00113724

Study of TPI 287 in Patients With Advanced Malignancies

A Phase I, Open-Label, Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Cortice Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Neoplasms
• Non-Hodgkin Lymphoma
• Hodgkin Disease

Interventions

Type	Name	Description
DRUG	TPI 287 Injection

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-06-10
• Last updated: 2009-06-04

Locations

4 sites across 1 country: United States