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Completed

NCT Number: NCT02643056

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panitumumab

Drug

IV administration every 2 weeks

Primary outcomes

  1. Rate of tumor response in advanced platinum-resistant head and neck cancer

    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

Secondary outcomes

  1. Adverse Event according to Common Terminology Criteria for Adverse Events (CTCAE) v.3

    Time frame: Collection of adverse event for at least the first 8 weeks

    To collect all adverse event occurred during the treatment

  2. Analysis of tumor biomarkers

    Time frame: 28 days (1 cycle)

    To identify the tumor biomarkers that can best predict response to panitumumab

Sponsors and collaborators

Lead sponsor

Southern Europe New Drug Organization

Other

Collaborators

  • Clinical Trial Unit Ente Ospedaliero Cantonale

Registry information

Official study title

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

Acronym: S10PANI01

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2015
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.