Study of Endostar Subcutaneous Injection in NSCLC

Phase 1

• Conditions: NSCLC
• Interventions: Drug: Endostar; Drug: Chemotherapy

• Registration Number: NCT02652234
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Status Verified: 2015-12
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-08
• Last Update Submitted: 2016-01-08
• Study First Posted: 2016-01-11
• Last Update Posted: 2016-01-11
• Primary Completion: 2016-06
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostar-subcutaneous injection/Chemotherapy	Chemotherapy	-
Endostar-subcutaneous injection/Chemotherapy	Endostar	-

Primary Outcome Measures

Name	Time	Method
incidence of adverse events	until 30 days after the last dose

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Jiangsu Province Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China