Clinical trial NCT02652234: Study of Endostar Subcutaneous Injection in NSCLC
Official title: A Single-arm, Open-label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Endostar Subcutaneous Injection in Chinese Advanced NSCLC Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: NSCLC
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: incidence of adverse events
timeFrame: until 30 days after the last dose
Secondary outcomes:
measure: Cmax
timeFrame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
measure: AUC
timeFrame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
measure: Tmax
timeFrame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
measure: T1/2
timeFrame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
measure: CL
timeFrame: day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Cancer Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Cancer Hospital
name: Jia Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Province Cancer Hospital
name: Lingxiang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: