Study of Endostar Subcutaneous Injection in NSCLC

NCT ID: NCT02652234

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-09-30

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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endostar-subcutaneous injection/Chemotherapy

Group Type: EXPERIMENTAL

Endostar

Intervention Type: DRUG

Endostar, ih, QD，day 1 of cycle 1; Endostar, ih, QD，day 2-15 of cycle 3;

Chemotherapy

Intervention Type: DRUG

Interventions

Endostar

Endostar, ih, QD，day 1 of cycle 1; Endostar, ih, QD，day 2-15 of cycle 3;

Intervention Type: DRUG

Chemotherapy

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Province Cancer Hospital

Lingxiang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Province Cancer Hospital

Locations

Jiangsu Province Cancer Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanhong Zhu

Role: CONTACT

86-025-85560000

Facility Contacts

Jia Chen

Role: primary

Lingxiang Chen

Role: backup

Other Identifiers

SIM-ED-201504

Identifier Type: -

Identifier Source: org_study_id