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A phase 3 trial of Palifermin in Head and neck squamous cell carcinoma, run by Swedish Orphan Biovitrum, completed.
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer is a phase 3 interventional study registered as NCT00101582 by Swedish Orphan Biovitrum, with 188 participants recorded, started 2005-08 and reaching its primary completion in 2007-09. Interventions recorded: Placebo, palifermin, cisplatin chemotherapy, Radiotherapy. Conditions recorded: Mucositis, Solid Tumors, Stomatitis, Head and Neck Cancer, Squamous Cell Carcinoma.
Linked to the drug Palifermin because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
188 enrolled.
Figures from the ClinicalTrials.gov results section (first posted 2014-09-15), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Number of Participants With Severe (Grade 3 or 4) Oral Mucositis, Yesprimary | Placebo | 94 | 62 participants | - | 0.0410 | link |
| Palifermin | 94 | 51 participants |
Shares Palifermin, Sobi (Swedish Orphan Biovitrum) and the tag pipeline.
Shares Palifermin, Sobi (Swedish Orphan Biovitrum) and the tag pipeline.
Shares Sobi (Swedish Orphan Biovitrum) and the tag pipeline.
Shares Head and neck squamous cell carcinoma and the tag pipeline.
Shares Head and neck squamous cell carcinoma and the tag pipeline.
Shares Head and neck squamous cell carcinoma and the tag pipeline.
Shares Head and neck squamous cell carcinoma and the tag pipeline.
Shares Head and neck squamous cell carcinoma and the tag pipeline.