Study of TRM-1(TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
August 1, 2013 updated by: Human Genome Sciences Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80220
- University of Colorado Cancer Center
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Medical College
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Cancer Center
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Texas
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Houston, Texas, United States, 77230
- MD Anderson
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
September 24, 2004
First Submitted That Met QC Criteria
September 27, 2004
First Posted (Estimate)
September 28, 2004
Study Record Updates
Last Update Posted (Estimate)
August 2, 2013
Last Update Submitted That Met QC Criteria
August 1, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRM1-ST03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.