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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00516672

Enrollment

Registered

2007-08-15

Start date

2007-09-10

Completion date

2015-10-14

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell

Keywords

lapatinib,, cancer, pharmacokinetics,, safety,, pazopanib,, Japanese patients,

Brief 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.

Interventions

DRUGpazopanib

Pazopanib oral tablet

DRUGLapatinib

Lapatinib oral tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	before and after taking the study medications	The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.

Secondary

Measure	Time frame	Description
Pharmacokinetics	over a 24 hour period	The pharmacokinetic parameters AUC0-24, AUC0-inf (Day 1 only), Cmax, tmax, and t1/2 of pazopanib and its four metabolites. To determine if target trough plasma concentration of pazopanib of 20,000 ng/ml is achieved.
Tumor response	9 weeks	Assessments of tumor response will be obtained every 9 weeks and will be recorded as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026