Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer

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

Timeline

Start

2011-01

Primary completion

2015-12

Completion

2015-12

Outcome

Missed primary endpoint

paper Two patients obtained a PR for an ORR of 6% PMID 28592616 ↗

Publications

• Siano M, Molinari F, Martin V, Mach N, Fruh M, Freguia S, Corradino I, Ghielmini M, Frattini M, Espeli V. Multicenter Phase II Study of Panitumumab in Platinum Pretreated, Advanced Head and Neck Squamous Cell Cancer. Oncologist. 2017 Jul;22(7):782-e70. doi: 10.1634/theoncologist.2017-0069. Epub 2017 Jun 7.

Drugs

Indications