NCT01019941

Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics of Docetaxel Between Two Docetaxel Products, CKD-810 and Taxotere Inj., in Patients With Advanced Solid Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety and the pharmacokinetic characteristics of docetaxel between two docetaxel products in patients with advanced solid cancer.

Detailed description

This is a Phase III study designed to evaluate the pharmacokinetic characteristics of docetaxel between two docetaxel products in patients with advanced solid cancer. This study will also assess the safety of the docetaxel in advanced solid cancer patients.

Conditions

• Advanced Solid Cancers

Interventions

Type	Name	Description
DRUG	CKD-810, Taxotere inj.	Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, CKD-810 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention.
DRUG	CKD-810, Taxotere inj.	Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, Taxotere inj. 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-08-01
• Completion: 2010-12-01
• First posted: 2009-11-25
• Last updated: 2010-12-16

Locations

7 sites across 1 country: South Korea