Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

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.