Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT02643056
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, not pregnant.
* Histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck either metastatic or recurrent, judged incurable by surgery or radiation.
* Baseline tumor tissue, sufficient material available for EGFR determination (therapeutic target of panitumumab) and biomarker studies. Patients without available tissue at baseline or with tissue collected longer than 1 year before, may undergo tumor biopsy.
* Progression after or not responding to treatment with at least one cis-platin or carboplatin containing regimen.
* Measurable disease (Response Evaluation Criteria in Solid Tumours - RECIST 1.1).
* Adequate hematological values, renal and hepatic function.
* Patients may not be receiving any other investigational agents
Exclusion Criteria:
* Platinum-naïve patients.
* Patients previously progressed after a regimen containing EGFR-inhibiting agents (as cetuximab, panitumumab, gefitinib, erlotinib), even if there was an initial response.
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization.
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest computed tomography scan.
* Known or suspected brain metastases.
* Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent
* Known hypersensitivity to panitumumab active ingredient or excipients.
* Any concomitant drugs contraindicated for use with the trial drug according to the Swissmedic approved product information - Human Immunodeficiency Virus (HIV) positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02643056
Study Brief:
Protocol Section:
NCT02643056