Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety
profile of panitumumab in patients affected by Head and Neck cancer after at least one
cisplatin or carboplatin-based chemotherapy. A translational research study is also planned
to evaluate Estimated Glomerular Filtration Rate (EGFR) status by FISH, KRAS, B-RAF, HRAS,
NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry,
and Human Papilloma Virus (HPV) genotyping by reverse hybridization.
Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive
disease, unacceptable toxicity, pregnancy, or patient's refusal
Phase:
Phase 2
Details
Lead Sponsor:
Southern Europe New Drug Organization
Collaborators:
Clinical Trial Unit Ente Ospedaliero Cantonale Clinical Trial Unit Ente Ospedaliero Cantonale (CTU-EOC)