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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: pazopanib
* Drug: Lapatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Pazopanib monotherapy or in combination with lapatinib | Drug: pazopanib<br>* Pazopanib oral tablet<br>Drug: Lapatinib<br>* Lapatinib oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | 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. | over a 24 hour period | 
| Tumor response | 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). | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lapatinib,, cancer, pharmacokinetics,, safety,, pazopanib,, Japanese patients,