NCT01099124

Brief Summary

The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 29, 2013

Status Verified

April 1, 2010

Enrollment Period

1.6 years

First QC Date

February 24, 2010

Last Update Submit

January 28, 2013

Conditions

Non Small Cell Lung Cancer

Keywords

M2ESNSCLCPhase I TrialAdvanced NSCLCRecurrent NSCLC

Outcome Measures

Primary Outcomes (1)

  • Adverse events incidence,including severe adverse events incidence

    one year

Secondary Outcomes (1)

  • Tumor response rate and disease controlled rate

    one year

Study Arms (1)

M2ES combined with chemotherapy

EXPERIMENTAL
Drug: M2ES

Interventions

M2ESDRUG

polyethylene glycol rh recombinant endostatin

M2ES combined with chemotherapy

Eligibility Criteria

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

You may qualify if:

  • Aged 18-70 years old;
  • Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
  • No contraindication for chemotherapy;
  • ECOG performance scale 0-2;
  • No history of anti-angiogenesis therapy;
  • Patients are voluntary to participate and sigh the informed contents.

You may not qualify if:

  • Concurrent use of other anti-cancer agents;
  • Allergic history to M2ES and biological agents;
  • Pregnant or breast-feeding women;
  • With other malignancy;
  • With severe cardiopulmonary disease;
  • Uncontrolled brain metastasis patients;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institude and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Kai LI

    Tianjin Medical University Cancer Institude and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

April 6, 2010

Study Start

December 1, 2009

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

January 29, 2013

Record last verified: 2010-04

Locations

CN(1)