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

NCT01019941 ↗

Phase 1 Completed 44 enrolled Chong Kun Dang Pharmaceutical

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2009-08
Primary completion: 2010-08
Completion: 2010-12

Publications

Cho EK, Park JY, Lee KH, Song HS, Min YJ, Kim YH, Kang JH. Open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD-810 and Taxotere injection, in patients with advanced solid cancer. Cancer Chemother Pharmacol. 2014 Jan;73(1):9-16. doi: 10.1007/s00280-013-2264-0. Epub 2013 Dec 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous

Indications

No indication recorded.