NCT00364754

Pharmacokinetic Study of Tesmilifene (YMB1002) Plus Epirubicin and Cyclophosphamide in Metastatic Breast Cancer

A PHARMACOKINETIC INTERACTION PHASE I, MULTI-CENTRE, OPEN-LABEL, CROSS-OVER Study Evaluating the Effect of Tesmilifene on the Plasma Pharmacokinetics of Epirubicin and Cyclophosphamide in Patients With Metastatic/Recurrent Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: YM BioSciences · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, multi-centre, open-label, cross-over pharmacokinetic study designed to investigate whether the co-administration of a fixed dose of tesmilifene alters the plasma pharmacokinetics of a standard regimen of epirubicin and/or its principle metabolite, epirubicinol and cyclophosphamide.

Detailed description

This is a Phase I, multi-centre, open-label, cross-over pharmacokinetic study designed to investigate whether the co-administration of a fixed dose of tesmilifene alters the plasma pharmacokinetics of a standard regimen of epirubicin and/or it's principle metabolite, epirubicinol and cyclophosphamide. The plasma pharmacokinetics of epirubicin/epirubicinol and cyclophosphamide when given alone or concurrently with tesmilifene will be examined. Safety information for the tesmilifene/ epirubicin and cyclophosphamide combination and for epirubicin and cyclophosphamide alone in this patient population will also be collected.

Conditions

• Metastatic/Recurrent Breast Cancer

Interventions

Type	Name	Description
DRUG	Tesmilifene (YMB 1002)

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2006-08-16
• Last updated: 2014-04-21

Locations

10 sites across 3 countries: Georgia, Russia, Ukraine