NCT00096668

Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast Cancer

A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(R) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) as Initial Treatment of Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2 every week for first line treatment of metastatic breast cancer. Patients will be followed to determine the efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of TOCOSOL Paclitaxel.

Detailed description

This is an open label, non-randomized Phase 2 study of weekly administration of TOCOSOL Paclitaxel at a dose level, 120mg/m2, known to be tolerated based on Phase 2a studies of this investigational agent in patients with other histological diagnoses. This study is a fixed sample size design with no planned early stopping decision. The goals of the study include the determination of the safety of TOCOSOL Paclitaxel, and the objective response rate, defined by RECIST criteria as complete responses plus partial responses.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	TOCOSOL(R) Paclitaxel

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2004-11-15
• Last updated: 2009-06-04

Locations

7 sites across 1 country: Russia