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Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer (S10PANI01)

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ClinicalTrials.gov Identifier: NCT02643056
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : December 30, 2015
Sponsor:
Collaborator:
Clinical Trial Unit Ente Ospedaliero Cantonale (CTU-EOC)
Information provided by (Responsible Party):
Tatiana Terrot, Oncology Institute of Southern Switzerland

December 8, 2015
December 30, 2015
December 30, 2015
January 2011
December 2015   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • Adverse Event according to 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
  • Analysis of tumor biomarkers [ Time Frame: 28 days (1 cycle) ]
    To identify the tumor biomarkers that can best predict response to panitumumab
Same as current
Not Provided
Not Provided
 
Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer
Phase II Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cance

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 EGFR status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry, and 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

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Head and Neck Squamous Cancer
Drug: Panitumumab
IV administration every 2 weeks
Experimental: Panitumumab
6 mg/kg per administration
Intervention: Drug: Panitumumab
Siano M, Molinari F, Martin V, Mach N, Früh 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Same as current
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 (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 CT 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 - HIV positive patients
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02643056
S10PANI01
No
Not Provided
Plan to Share IPD: No
Tatiana Terrot, Oncology Institute of Southern Switzerland
Southern Europe New Drug Organization
Clinical Trial Unit Ente Ospedaliero Cantonale (CTU-EOC)
Study Chair: Michele Ghielmini, Prof Oncology Institute of Southern Switzerland
Southern Europe New Drug Organization
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP