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Study of Endostar Subcutaneous Injection in NSCLC

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02652234
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
13
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endostar-subcutaneous injection/Chemotherapy

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

Drug: Chemotherapy

Outcome Measures

Primary Outcome Measures

  1. incidence of adverse events [until 30 days after the last dose]

Secondary Outcome Measures

  1. 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]

  2. 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]

  3. 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]

  4. 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]

  5. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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≥1.5×109/L, Hb≥90g/L, PLT≥100×109/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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Province Cancer Hospital Nanjing Jiangsu China 210000

Sponsors and Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jia Chen, MD, Jiangsu Province Cancer Hospital
  • Principal Investigator: Lingxiang Chen, MD, Jiangsu Province Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02652234
Other Study ID Numbers:
  • SIM-ED-201504
First Posted:
Jan 11, 2016
Last Update Posted:
Jan 11, 2016
Last Verified:
Dec 1, 2015
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Endostar protein

Study Results

No Results Posted as of Jan 11, 2016