Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck Cancer

Inclusion Criteria: Male and female patients (18 years old and above), with a histologically proven, measurable, locally recurrent, and/or metastatic head and neck tumor. > 4 weeks since major surgery > 4 weeks since prior chemotherapy > 3 weeks since prior therapy with biological agents (Interleukin-2 [IL-2], interferon, other molecular-targeted therapies [except Ras/Raf inhibitors]). Performance status < 2 Life expectancy > 3 months. At least one uni-dimensional measurable lesion by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) Adequate liver, pancreatic, renal, and coagulation function A slide or paraffin-block from a tumor biopsy MUST be available at the time of screening. If the original diagnostic biopsy is not available at the time of screening, an additional biopsy is required. Exclusion Criteria: Severe preexisting conditions Evidence of bone marrow suppression Frequent vomiting or medical condition, which could interfere with oral medication intake Lack of resolution of all toxic manifestations of prior chemotherapy, biologic, or radiation therapy (alopecia excluded). Known HIV positivity or AIDS-related illness. Previous exposure to a Ras/Raf inhibitor Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry) Congestive heart failure Cardiac arrhythmias requiring anti-arrhythmics Active coronary artery disease or ischaemia Active clinically serious bacterial or fungal infections Known brain or meningeal metastases Patients with seizure disorder requiring medication (such as anti-epileptics) Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results Known or suspected allergy to the investigational agent or any agent given in association with this trial Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test. Concurrent anti-cancer chemotherapy or immunotherapy is excluded Significant surgery within four weeks prior to start of study drug Investigational drug therapy outside of this trial, or any chemotherapy during or within 4 weeks prior to start of study drug Myelosuppressive radiotherapy within four weeks prior to start of study drug (short-course non-myelosuppressive radiotherapy may be allowed based on approval of principal investigators) Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice