CClinicalTrials.gg
Status unknownNCT02652234Updated Jan 11, 2016

Study of Endostar Subcutaneous Injection in NSCLC

A Phase 1 interventional study of Endostar and Chemotherapy in NSCLC, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-01-11.

Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 8 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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≥1.5×10\^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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Endostar-subcutaneous injection/Chemotherapy

    Drug: Endostar · Drug: Chemotherapy

Interventions

  • DrugEndostar

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

  • DrugChemotherapy
06

What researchers measure

Primary outcomes

  1. incidence of adverse events

    Time frame: until 30 days after the last dose

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

1 of 1 sites recruiting
  • Jiangsu Province Cancer Hospital
    Nanjing, Jiangsu 210000, China
    • Jia Chen · Contact
    • Lingxiang Chen · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02652234
Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 11, 2016
Start date
Aug 2015
Primary completion
Jun 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Jan 11, 2016

Study contacts

Yanhong Zhu
Contact
86-025-85560000
Jia Chen, MD
principal investigator · Jiangsu Province Cancer Hospital
Lingxiang Chen, MD
principal investigator · Jiangsu Province Cancer Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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