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