NCT00881101

Clinical Study of Liposomal Paclitaxel in Chinese Patients

Dose Escalation Study of Liposomal Paclitaxel in Chinese Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Nanjing Sike Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.

Detailed description

There are clinical trials show that paclitaxel is common option for the treatment of solid tumors. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional paclitaxel. However,the tolerance of this new dosage form of paclitaxel (liposomal paclitaxel) has never been studied in Chinese cancer patients. This study is designed to find the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese cancer patients.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Liposomal paclitaxel	All Patients will receive liposomal paclitaxel (starting at a dose of 190mg/m2,3h,ivgtt,at d1)each cycle for 1 cycle.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2009-04-15
• Last updated: 2009-04-15

Locations

1 site across 1 country: China