NCT00364195

Tesmilifene in Combination With Docetaxel in the Treatment of Metastatic Breast Cancer

A Pharmacokinetic Interaction and Safety and Efficacy Phase II, Open Label Study With a Safety Lead-in Evaluating Docetaxel Plus Tesmilifene (YMB1002) in Patients With Metastatic Breast Cancer Suitable for Treatment With Docetaxel

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: YM BioSciences · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II study designed to evaluate whether the co-administration of a fixed dose of tesmilifene and a standard regimen of docetaxel alters the plasma pharmacokinetics of docetaxel. This study will also assess the safety and efficacy of the tesmilifene/docetaxel combination in metastatic breast cancer patients.

Detailed description

Primary Objective: 1\. To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone. Secondary Objectives: 1. To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion. 2. To collect safety information for tesmilifene when administered in combination with docetaxel. 3. To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Tesmilifene (YMB1002)

Timeline

• Start date: 2006-06-01
• First posted: 2006-08-15
• Last updated: 2009-01-09

Locations

3 sites across 1 country: Serbia