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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Carcinoma, Renal Cell

Treatments

Drug: pazopanib

Drug: Lapatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00516672

109693

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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