NCT00606515

Pharmacokinetics Study of Liposomal Paclitaxel in Humans

A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Shandong Luye Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.

Detailed description

The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Liposomal paclitaxel	Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
DRUG	Paclitaxel	Patients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-02-04
• Last updated: 2009-02-10

Locations

2 sites across 1 country: China