A Phase 1/2 interventional study of Placebo and palifermin in Head and Neck Cancer, sponsored by Swedish Orphan Biovitrum. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-02.
Sponsored by Swedish Orphan Biovitrum · Phase 1/2, Interventional, and Supportive care
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.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
Browse Head and Neck Neoplasms studies →Swedish Orphan Biovitrum is the lead sponsor of 80 studies on the registry; 4 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
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Exclusion Criteria:
Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows: * PK cohort will be randomized in a 3:1 ratio \[palifermin: placebo\] in at least 12 subjects * Non-PK cohort will be randomized in a 1:1 ratio \[palifermin: placebo\] in up to 28 subjects.
Drug: Placebo
Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows: * PK cohort will be randomized in a 3:1 ratio \[palifermin: placebo\] in at least 12 subjects * Non-PK cohort will be randomized in a 1:1 ratio \[palifermin: placebo\] in up to 28 subjects.
Drug: palifermin
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.
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
Incidence of treatment-emergent proteinuria
Time frame: 11 weeks
Duration of treatment-emergent proteinuria
Time frame: 11 weeks
Incidence of chronic proteinuria
Time frame: 11 weeks
Time (days) to onset of treatment-emergent proteinuria
Time frame: 11 weeks
Maximum protein-to-creatinine ratio values during the treatment period
Time frame: 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
Time frame: in Week 1
Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4
Time frame: 11 weeks
Disease status at End of Treatment visit
Time frame: 11 weeks
Incidence of serum anti-palifermin antibody formation
Time frame: 11 weeks
Incidence of second primary tumors
Time frame: up to 10 years (Long-Term Follow-Up phase)
Incidence of other malignancies
Time frame: up to 10 years (Long-Term Follow-Up phase)
Progression-free survival
Time frame: up to 10 years (Long-Term Follow-Up phase)
Overall survival
Time frame: up to 10 years (Long-Term Follow-Up phase)
Incidence of adverse events and laboratory abnormalities
Time frame: 11 weeks
Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4
Time frame: 11 weeks
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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