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:
Human Genome Sciences Inc., a GSK Company
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00092924
First received: September 24, 2004
Last updated: October 29, 2012
Last verified: October 2012
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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 GlaxoSmithKline:
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
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., a GSK Company
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: | October 29, 2012 |
| 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 May 22, 2013