Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors.
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 13, 2007
Last updated: April 11, 2013
Last verified: February 2013
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: before and after taking the study medications ] [ Designated as safety issue: No ]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:
- Pharmacokinetics [ Time Frame: over a 24 hour period ] [ Designated as safety issue: No ]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 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]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).
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Pazopanib monotherapy or in combination with lapatinib
Pazopanib oral tabletDrug: Lapatinib
Lapatinib oral tablet
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