Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
- Registration Number
- NCT00516672
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 pazopanib Pazopanib monotherapy or in combination with lapatinib Arm 1 Lapatinib Pazopanib monotherapy or in combination with lapatinib
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
GSK Investigational Site
🇯🇵Saitama, Japan