Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)

Phase I Study to Determine the Safety, Maximum Tolerated Dose, PK of BAY43-9006 in Repeated Cycles of 18 Days On/3 Days Off in Combination With Paclitaxel and Carboplatin Chemotherapy in Patients With Advanced, Refractory Solid Tumors

The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors.

The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.

Inclusion Criteria:

• Histologically confirmed solid tumors
• Evaluable disease
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Life expectancy minimum 12 weeks

Exclusion Criteria:

• Congestive heart failure
• Serious arrhythmias
• Coronary artery disease (CAD) or ischemia
• HIV (human immunodeficiency virus)
• Hepatitis B or C
• Serious active infection
• Metastatic brain or meningeal tumors