Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00131638 | A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer | PHASE3 | COMPLETED | 241 | — | — | Jan 1, 2005 | Jul 1, 2016 | Dec 16, 2016 | - | — |
| Arm | Type | Description |
|---|---|---|
| Palifermin | EXPERIMENTAL | Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course |
| Placebo | PLACEBO_COMPARATOR | Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course. |
| Palifermin | DRUG | Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course |
Inclusion Criteria: * History of histologically documented squamous cell carcinoma ( AJCC \[American Joint Committee on Cancer\] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT * Radia...