NCT01268163

The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer

A Phase 1, Double-blinded, Randomised, Multi-centre, Three-period, Three-treatment, Crossover Study to Compare the Intravenous Pharmacokinetic and Safety Characteristics of European Taxotere® and American Taxotere® With Hospira Docetaxel Injection Administered at a Therapeutic Dose in Cancer Patients.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the pharmacokinetic and safety characteristics of European Taxotere® and American Taxotere® with Hospira Docetaxel injection in patients with cancer.

Detailed description

No information is available on the pharmacokinetic characteristics, safety or efficacy of Hospira Docetaxel Injection. The primary purpose of this study therefore is to compare the pharmacokinetic characteristics of 60-100 mg/m² Hospira Docetaxel Injection, 60-100 mg/m² European Taxotere® (Taxotere® EU) and 60-100 mg/m² American Taxotere® (Taxotere® US) when administered as a 1 hour intravenous infusion in man. The secondary objective of this study will be to compare the safety and tolerability of Hospira Docetaxel Injection, Taxotere® EU and Taxotere® US. The study will also provide an opportunity to assess selected efficacy endpoints according to local practice after each cycle of treatment. The study dosing regimen (60-100 mg/m², administered as a 1 hour intravenous infusion at 3 week intervals) and subject population (cancer patients for whom Taxotere® monotherapy would be a suitable treatment option) were selected on the basis of the licensed use of 60-100 mg/m² Taxotere®. The randomised crossover design was chosen to reduce the effect of intersubject variation. Since Hospira Docetaxel Injection has not been administered to man there is no information on the risks associated with its clinical use. However the active ingredient of Hospira Docetaxel Injection is the same as that of Taxotere® and it is expected that Hospira Docetaxel Injection will exhibit a similar safety and tolerability profile. An estimated 24 patients will be recruited at several United Kingdom sites and one Russian site to provide 19 evaluable patients

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	European Taxotere®	60-100 mg/m\^2 IV
DRUG	American Taxotere®	60-100 mg/m\^2 IV
DRUG	Hospira Docetaxel Injection	60-100 mg/m\^2 IV

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2010-12-29
• Last updated: 2017-03-20

Locations

4 sites across 2 countries: Russia, United Kingdom