Study of Endostar Subcutaneous Injection in NSCLC

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Endostar protein

Criteria

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