Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors

A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors

This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.

Inclusion criteria:

• Signed informed consent.
• Histologically or cytologically confirmed diagnosis of advanced solid tumor.
• Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.
• ECOG performance status of 0 or 1.
• Adequate bone marrow reserve and hepato-renal function.
• Able to swallow and retain oral medication.
• For combo part, left ventricular ejection fraction within normal range or above 50%.

Exclusion criteria:

• Prior treatment with pazopanib, and with lapatinib for combo part.
• Clinically significant gastrointestinal abnormalities.
• Sevier diseases or conditions other than cancer.
• Poorly controlled hypertension.
• Use of warfarin for therapeutic anticoagulation.
• Use of other anti-angiogenesis agents, and other ErbB inhibitors for combo part.
• Unresolved and/or unstable toxicities
• Pregnant or lactating females