Study of Endostar Subcutaneous Injection in NSCLC

Simcere

Status and phase

Unknown

Phase 1

Conditions

NSCLC

Treatments

Drug: Chemotherapy

Drug: Endostar

Study type

Interventional

Funder types

Industry

Identifiers

NCT02652234

SIM-ED-201504

Details and patient eligibility

About

This is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.

Enrollment

8 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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