Who is sponsoring NCT02283476?

NCT02283476 is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

What condition does NCT02283476 study?

NCT02283476 studies Lung Cancer.

What drugs are being tested in NCT02283476?

Interventions: Endostar continuous intravenous infusion, Endostar routine intravenous infusion, Gemcitabine, Cisplatin.

What is the status of NCT02283476?

NCT02283476 is currently UNKNOWN.

Last reviewed 2014-11-05 · How we verify

The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.

NCT02283476 Phase 3 UNKNOWN

Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells，CECs, will be explored in the study.

Details

Lead sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	200
Start date	2014-11
Completion	2017-11

Conditions

Lung Cancer

Interventions

Endostar continuous intravenous infusion
Endostar routine intravenous infusion
Gemcitabine
Cisplatin

Primary outcomes

objective response rate based on Recist 1.1 edition — 3 months
progress free survival — 18 months

Countries

China