CLINICAL TRIAL: PHASE 1 AND PHARMACOKINETIC SINGLE AGENT STUDY OF PAZOPANIB ADVA

University Of Southern California, Los Angeles CA

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Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Objectives of this study are to establish the MTD and DLT of pazopanib in groups of patients with varying degrees of hepatic dysfunction in order to provide appropriate dosing recommendations for pazopanib in such patients, to characterize the PK and PD profiles of pazopanib and metabolites, to document the non-DLTs;to explore correlations of the Child-Pugh classification of hepatic dysfunction with the observed toxicities, plasma PK, and PD of pazopanib administration, and to document any antitumor activity associated with pazopanib treatment. The trial is expected to accrue patients at a rate of approximately 5 patients per month for a total accrual of 72-132 patients. Pazopanib is a potent, multi-targeted receptor tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-[unreadable], PDGFR-[unreadable], and c-kit and has shown activity in renal cell cancer with tumor shrinkage and stable disease. Current phase I, II, and III trials of pazopanib as single therapy and in combination with lapatinib are ongoing or planned for patients with liver cancer, metastatic renal cell carcinoma, malignant glioma, non-small cell lung cancer, advanced breast cancer, multiple myeloma, ovarian cancer, and various types of sarcomas.