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The 20070201 study was terminated based on evaluation of Palifermin solid tumor data.
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows:
|
|
| Palifermin | Experimental | Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent proteinuria | 11 weeks | |
| Duration of treatment-emergent proteinuria | 11 weeks | |
| Incidence of chronic proteinuria | 11 weeks | |
| Time (days) to onset of treatment-emergent proteinuria | 11 weeks | |
| Maximum protein-to-creatinine ratio values during the treatment period | 11 weeks | |
| Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time | in Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4 | 11 weeks | |
| Disease status at End of Treatment visit | 11 weeks | |
| Incidence of serum anti-palifermin antibody formation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Biovitrum AB (publ) | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| palifermin | Drug | 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 |
|
| 11 weeks |
| Incidence of second primary tumors | up to 10 years (Long-Term Follow-Up phase) |
| Incidence of other malignancies | up to 10 years (Long-Term Follow-Up phase) |
| Progression-free survival | up to 10 years (Long-Term Follow-Up phase) |
| Overall survival | up to 10 years (Long-Term Follow-Up phase) |
| Incidence of adverse events and laboratory abnormalities | 11 weeks |
| Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4 | 11 weeks |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D051523 | Fibroblast Growth Factor 7 |
| ID | Term |
|---|---|
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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