NCT00092924

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

September 24, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2013

First QC Date

September 24, 2004

Last Update Submit

August 1, 2013

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TRAIL-R1 mAb (TRM-1;HGS-ETR1)DRUG

Eligibility Criteria

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

You may qualify if:

  • Relapsed or refractory histologically or cytologically confirmed Stage IIIB, IV, or recurrent NSCLC
  • Previously treated and failed to respond to standard therapy or progressed after standard therapy
  • years of age or older

You may not qualify if:

  • Received a non-FDA approved investigational agent within the last 4 weeks.
  • Previous cancer therapies (chemotherapy, hormonal therapy, monoclonal antibodies or radiation therapy) within the last 3 weeks, 8 weeks for fully human or humanized monoclonal antibodies
  • Infection requiring antibiotics or hospitalization within the last 2 weeks
  • HIV, Hepatitis-B, Hepatitis-C
  • Pregnant or breast-feeding women
  • Major surgery within the last 4 weeks
  • History of other cancers within the past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado Cancer Center

Denver, Colorado, 80220, United States

Location

Rush Medical College

Chicago, Illinois, 60612, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

MD Anderson

Houston, Texas, 77230, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

mapatumumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 24, 2004

First Posted

September 28, 2004

Primary Completion

January 1, 2005

Study Completion

March 1, 2005

Last Updated

August 2, 2013

Record last verified: 2013-08

Locations

US(5)