Clinical Trial Details

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Study ID 20062088
Investigator
MD,   Amgen
Title PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
Conditions Cancer
Carcinoma
Head and Neck Cancer
Metastases
Metastatic Cancer
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Oncology
Squamous Cell Carcinoma
Tumors
Interventions Drug: Panitumumab
Phase Phase 2
Purpose This is an open-label, single-arm, phase 2, multi-center, clinical trial of panitumumab monotherapy for second-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN) subjects. This study will be conducted in North America. Approximately 50 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN will be enrolled into the trial.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Histologically or cytologically confirmed squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using CT or MRI scan
  • Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy
  • Karnofsky Performance Status (KPS) score ≥ 60% at screening
  • Men or women age ≥18 years
  • Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test Exclusion Criteria:
  • Subject received > 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
  • Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
  • Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
  • History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
  • Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
  • Known allergy or hypersensitivity to any component of panitumumab
  • Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions: - Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed > 24 weeks prior to randomization
  • Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.
  • Significant thromboembolic event ≤ 8 weeks prior to enrollment
  • Subjects not recovered from all previous acute radiotherapy-related toxicities
  • History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
  • History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
  • Subject is currently in a clinical trial ≤ 30 days prior to enrollment
  • Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
  • Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
  • Female subject who is pregnant or breast-feeding
  • Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.
  • Study Location N/A
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 10/26/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00446446


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