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Study of Endostar Subcutaneous Injection in NSCLC

Primary Purpose

NSCLC

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Endostar
Chemotherapy
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jiangsu Province Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endostar-subcutaneous injection/Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

incidence of adverse events

Secondary Outcome Measures

Cmax
AUC
Tmax
T1/2
CL

Full Information

First Posted
January 6, 2016
Last Updated
January 8, 2016
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02652234
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endostar-subcutaneous injection/Chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Endostar
Intervention Description
Endostar, ih, QD，day 1 of cycle 1; Endostar, ih, QD，day 2-15 of cycle 3;
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Primary Outcome Measure Information:
Title
incidence of adverse events
Time Frame
until 30 days after the last dose
Secondary Outcome Measure Information:
Title
Cmax
Time Frame
day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
Title
AUC
Time Frame
day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
Title
Tmax
Time Frame
day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
Title
T1/2
Time Frame
day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks
Title
CL
Time Frame
day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanhong Zhu
Phone
86-025-85560000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Chen, MD
Organizational Affiliation
Jiangsu Province Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lingxiang Chen, MD
Organizational Affiliation
Jiangsu Province Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Chen
First Name & Middle Initial & Last Name & Degree
Lingxiang Chen

12. IPD Sharing Statement

Learn more about this trial

Study of Endostar Subcutaneous Injection in NSCLC

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