Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in Patients With Advanced, Refractory Solid Tumors

Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients

Inclusion Criteria:

• At least 18 years old
• Advanced histological or cytological documentation of cancer
• life-expectancy of at least 12 weeks
• able to swallow pills
• ECOG status of 0,1 or 2
• adequate bone marrow
• liver and renal function

Exclusion Criteria:

• > NYHA Class 2 CHF
• Serious myocardial dysfunction,
• or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)
• History of organ allograft
• uncontrolled hypertension
• renal dialysis
• Bleeding event/hemorrhage within 4 weeks of study treatment
• major surgery within 4 weeks of study treatment
• Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose