| Exclusion Criteria: | 1) Laboratory values (SI Units): Absolute Neutrophil Count (ANC) <1.5 x 10^9/L (1500 per mm^3); Platelets <100 x 10^9/L (100,000 per mm^3); Hemoglobin (Hgb) <9.0 g/dL; serum bilirubin >/= 1.5x Upper Limit of Normal (ULN); aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)>/= 2.5 x ULN; and serum calcium >1 x ULN and phosphate >1 x ULN; serum calcium (corrected for albumin^2) outside of normal limits; phosphate outside of normal limits; and serum potassium or magnesium outside of normal limits.
2) Any radiotherapy, biological or chemotherapy within 21 days prior to starting the study (not including palliative radiotherapy at focal sites) or who have not recovered from side effects of their treatment
3) Participation in an investigational drug study within the 30 days prior to entry or who have not recovered from clinically significant side effects of an investigational study drug
4) Brain metastases or spinal cord compression unless treated and stable off steroids and anticonvulsants (for at least 1 month)
5) Female patients who are breast feeding, or patients of reproductive potential not employing an effective method of birth control
6) Any evidence of severe or uncontrolled systemic disease (e.g., severe hepatic impairment, severe renal impairment uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy
7) Parathyroid disorder or history of malignancy associated hypercalcemia
8) Evidence of active infection or active bleeding diatheses
9) Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment
10) Patients with documented cases of human immunodeficiency virus (HIV) or hepatitis B or C
11) Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
12) Previous treatment with a MEK inhibitor
13) Mean QT interval > 450ms
14) Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
15) Previous enrollment or randomization of treatment in the present study
16) Clinical judgement by the Investigator that the patient should not participate in the study |