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
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: TRAIL-R1 mAb (TRM-1;HGS-ETR1)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Human Genome Sciences Inc.:

Study Completion Date: March 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092924

Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80220
United States, Illinois
Rush Medical College
Chicago, Illinois, United States, 60612
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson
Houston, Texas, United States, 77230
Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00092924     History of Changes
Other Study ID Numbers: TRM1-ST03
Study First Received: September 24, 2004
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014