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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00094861 |
The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).
Condition | Intervention | Phase |
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Dysphagia Non-Small Cell Lung Cancer Lung Cancer |
Drug: Palifermin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy Followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC) |
Enrollment: | 100 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | February 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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II: Placebo Comparator |
Drug: Placebo
A total of approximately 50 adult subjects with unresectable stage III NSCLC will receive intravenous placebo at single weekly doses of 180 micrograms/kg to be administered on the Friday before the initiation of concurrent chemo-radiotherapy and on the last day of each chemotherapy/ radiotherapy treatment week following the last dose of radiation therapy of the week (a total of 7 doses).
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I: Experimental |
Drug: Palifermin
A total of approximately 50 adult subjects with unresectable stage III NSCLC will receive intravenous palifermin at single weekly doses of 180 micrograms/kg to be administered on the Friday before initiation of concurrent chemo-radiotherapy and on the last day of each chemotherapy/ radiotherapy treatment week following the last dose of radiation therapy of the week (a total of 7 doses).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20030185 |
Study First Received: | October 27, 2004 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00094861 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Agencia Española de Medicamentos y Productos Sanitarios; United States: Food and Drug Administration |
dysphagia palifermin, KGF chemoradiotherapy NSCLC, non-small cell lung cancer lung cancer |
supportive care clinical trial consolidation chemotherapy radiotherapy |
Thoracic Neoplasms Non-small cell lung cancer Otorhinolaryngologic Diseases Esophageal disorder Gastrointestinal Diseases Pharyngeal Diseases Carcinoma Deglutition Disorders |
Digestive System Diseases Respiratory Tract Diseases Lung Neoplasms Lung Diseases Esophageal Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |