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

• Status: Completed
• Trial end date: 2015-10-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lapatinib

Criteria

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