Study of TRM-1(TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00092924
First received: September 24, 2004
Last updated: August 1, 2013
Last verified: August 2013

September 24, 2004
August 1, 2013
Not Provided
January 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00092924 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of TRM-1(TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
A Phase 2, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of TRM-1 (Fully Human Monoclonal Antibody To TRAIL-R1) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
Drug: TRAIL-R1 mAb (TRM-1;HGS-ETR1)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2005
January 2005   (final data collection date for primary outcome measure)

Primary Inclusion Criteria:

  • 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
  • 18 years of age or older

Primary Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00092924
TRM1-ST03
Not Provided
Not Provided
Human Genome Sciences Inc.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
Human Genome Sciences Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP