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| Sponsored by: |
Amgen |
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00540332 |
Purpose
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.
| Condition | Intervention | Phase |
|
Head and Neck Cancer |
Drug: Placebo Drug: palifermin |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| ChemIDplus related topics: | Palifermin Fibroblast growth factor 7 |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows:
|
Drug: Placebo
Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.
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Palifermin: Experimental
Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows:
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Drug: palifermin
120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Czech Republic | |||||
| Research Site | |||||
| Brno, Czech Republic | |||||
| Research Site | |||||
| Prague 8, Czech Republic | |||||
| France | |||||
| Research Site | |||||
| Angers, France | |||||
| Germany | |||||
| Research Site | |||||
| Freiburg, Germany | |||||
| Research Site | |||||
| Homburg, Germany | |||||
| Research Site | |||||
| Leipzig, Germany | |||||
| Amgen |
| Study Director: | MD | Amgen |
More Information
AmgenTrials clinical trials website 
  |
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20070201 |
| First Received: | October 4, 2007 |
| Last Updated: | August 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00540332 |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United States: Food and Drug Administration; Czech Republic: Statni ustav pro kontrolu leciv; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices |
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