NSCLC
Conditions
Brief summary
This is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.
Interventions
DRUGEndostar
Endostar, ih, QD，day 1 of cycle 1; Endostar, ih, QD，day 2-15 of cycle 3;
DRUGChemotherapy
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histological/cytological confirmed unresectable stage ⅢB～Ⅳ non-squamous NSCLC * ECOG performance status 0-1 * Life expectancy≥3 months * Adequate hematologic function: WBC≥3.0×109/L ,ANC≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L; * Adequate hepatic and renal function: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN, creatinine≤1×ULN, creatinine clearance≥50ml/min; * Normal coagulation function (PT, APTT, TT, Fbg) ; * Patients signed informed consent form; * Willingness and capability to comply with protocol requirement and well communicate with investigators.
Exclusion criteria
* With uncontrolled ascites or pleural effusion; * Patients receiving a chest or abdominal surgery within 28 days before enrollment; or with not fully healed surgical incision; or expected to receive surgery during the study; * History of ischemic or TIA within 6 months before enrollment; * Uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy; * Arrhythmias need to be treated; history of coronary artery disease (including angina pectoris and myocardial infarction) or ischemic myocardium; congestive heart-failure NYHA class ≥ II； * Serious active infections; * History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment; * Symptomatic brain or meningeal metastasis; * Epileptic seizure need to be treated; * HCV, HBV or HIV positive; * History of other malignant tumors within 5 years (except curable cervix carcinoma in situ or skin basal cell carcinoma); * Known allergies to any excipient in the study drug; * Any conditions that may interfere with the patient's participation in the study or have an impact on the assessment of the results of the study; * Any conditions that may endanger patient safety or interfere with the patient's compliance; * Pregnant and lactating women; * The investigators consider the patients unsuitable for this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse events | until 30 days after the last dose |
Secondary
| Measure | Time frame |
|---|---|
| Cmax | 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 | 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 | 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 | 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 | day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks |
Countries
China
Contacts
Primary ContactYanhong Zhu
Outcome results
None listed