Panitumumab
DrugIV administration every 2 weeks
NCT Number: NCT02643056
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
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV administration every 2 weeks
Time frame: Radiological tumor evaluation every 8 weeks, minimum 12 weeks
To evaluate rate of radiological tumor response in advanced platinum-resistant head and neck cancer
Time frame: Collection of adverse event for at least the first 8 weeks
To collect all adverse event occurred during the treatment
Time frame: 28 days (1 cycle)
To identify the tumor biomarkers that can best predict response to panitumumab
Southern Europe New Drug Organization
Other
Phase II Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cance
Acronym: S10PANI01
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.