Study of Endostar Subcutaneous Injection in NSCLC

NSCLC Clinical Trial

Official title:

A Single-arm, Open-label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Endostar Subcutaneous Injection in Chinese Advanced NSCLC Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02652234
• Other study ID #: SIM-ED-201504
• Status: Recruiting
• Phase: Phase 1
• First received: January 6, 2016
• Last updated: January 8, 2016
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2015
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Yanhong Zhu
• Phone: 86-025-85560000
• Is FDA regulated: No
• Health authority: China: Jiangsu Provincial Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histological/cytological confirmed unresectable stage ?B~? 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Endostar
Endostar, ih, QD,day 1 of cycle 1; Endostar, ih, QD,day 2-15 of cycle 3;
• Chemotherapy

Locations

Country	Name	City	State
China	Jiangsu Province Cancer Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse events		until 30 days after the last dose	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes