NCT02652234

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 11, 2016

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

January 6, 2016

Last Update Submit

January 8, 2016

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

  • incidence of adverse events

    until 30 days after the last dose

Secondary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Endostar-subcutaneous injection/Chemotherapy

EXPERIMENTAL
Drug: EndostarDrug: Chemotherapy

Interventions

EndostarDRUG

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

Endostar-subcutaneous injection/Chemotherapy
ChemotherapyDRUG
Endostar-subcutaneous injection/Chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Province Cancer Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

endostar proteinDrug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jia Chen, MD

    Jiangsu Province Cancer Hospital

    PRINCIPAL INVESTIGATOR

  • Lingxiang Chen, MD

    Jiangsu Province Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanhong Zhu

CONTACT

86-025-85560000

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 11, 2016

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

January 11, 2016

Record last verified: 2015-12

Locations

CN(1)