Study of Pazopanib and Paclitaxel in Advanced Non-small Cell Lung Cancer

Inclusion criteria

• Written informed consent
• At least 18 years old
• Histologically- or cytologically-confirmed diagnosis of Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC (or for Phase I only, advanced solid tumor for which there is no standard therapy or for whom paclitaxel is standard therapy).
• No prior systemic first-line therapy for advanced disease
• Measurable disease
• ECOG performance status of 0 or 1
• Life expectancy of at least 12 weeks.
• Able to swallow and retain oral medication
• Adequate organ system function (hematological, renal, and hepatic)
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception

Exclusion criteria

• Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC (or for Phase I, other than the primary solid tumor)
• CNS metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
• Clinically significant gastrointestinal abnormalities
• Prolongation of corrected QT interval (QTc) > 480 msecs
• History of any one or more cardiovascular conditions within the past 6 months prior to randomization
• Poorly controlled hypertension
• History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
• Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
• Evidence of active bleeding or bleeding diathesis
• Recent hemoptysis
• Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
• Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
• Use of any prohibited medication
• Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
• Ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity except alopecia
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, paclitaxel, and/or carboplatin.