A Phase I Double-blinded, Randomized 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.
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
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 UK sites and one Russian site to
provide 19 evaluable patients
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
AUC (0-tlast); Cmax
Day -21 through Day 57
Christie Hospital, Manchester
United Kingdom: Medicines and Healthcare Products Regulatory Agency