MedTrace Logo

Pharmacokinetics Study of Liposomal Paclitaxel in Humans

NCT00606515 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2009-02-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nanjing Sike Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shandong Luye Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Li, Doctor · Cancer Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00606515 on ClinicalTrials.gov