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Study of Endostar Subcutaneous Injection in NSCLC

S

Simcere

Status and phase

Unknown
Phase 1

Conditions

NSCLC

Treatments

Drug: Chemotherapy
Drug: Endostar

Study type

Interventional

Funder types

Industry

Identifiers

NCT02652234
SIM-ED-201504

Details and patient eligibility

About

This is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.

Enrollment

8 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Endostar-subcutaneous injection/Chemotherapy
Experimental group
Treatment:
Drug: Chemotherapy
Drug: Endostar

Trial contacts and locations

1

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Central trial contact

Yanhong Zhu

Data sourced from clinicaltrials.gov

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