A Phase 1 interventional study of Endostar and Chemotherapy in NSCLC, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-01-11.
Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
This is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 8 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Endostar · Drug: Chemotherapy
Endostar, ih, QD,day 1 of cycle 1; Endostar, ih, QD,day 2-15 of cycle 3;
incidence of adverse events
Time frame: until 30 days after the last dose
Cmax
Time frame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
AUC
Time frame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
Tmax
Time frame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
T1/2
Time frame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
CL
Time frame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Jiangsu Simcere Pharmaceutical Co., Ltd.