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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00480025 |
The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Tumor Antigen-Positive Non-Small Cell Lung Cancer |
Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic Biological: Placebo Control |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer |
Estimated Enrollment: | 2270 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2015 |
Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo Group: Placebo Comparator |
Biological: Placebo Control
Intramuscular administration, 13 doses
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ASCI Group: Experimental |
Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Intramuscular administration, 13 doses
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"http://www.immunotherapyforcancer.info provides information on the cancer immunotherapeutic approach in an easy-to-understand format" "http://www.ascitrials.com gives practical information on the MAGRIT clinical study"
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as: Absolute neutrophil count ≥ 1.0 x 10E9/L Platelet count ≥ 75 x 10E9/L Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN)
Exclusion criteria
Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted.
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 109493 |
Study First Received: | May 29, 2007 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00480025 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-small-cell lung cancer Immunotherapeutic Adjuvant cancer therapy |
Tumor antigen ASCI MAGRIT |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adjuvants, Immunologic |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |