Severe and fatal hepatotoxicity has been observed in clinical studies. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. [See Warnings and Precautions .]
VOTRIENT (pazopanib) is a tyrosine kinase inhibitor (TKI).
VOTRIENT™ is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
Published Studies Related to Votrient (Pazopanib)
Association of the hemochromatosis gene with pazopanib-induced transaminase elevation in renal cell carcinoma. [2011.06]
BACKGROUND & AIMS: Pazopanib has demonstrated clinical benefit in patients with advanced renal cell carcinoma (RCC) and is generally well tolerated. However, transaminase elevations have commonly been observed. This 2-stage study sought to identify genetic determinants of alanine transaminase (ALT) elevations in pazopanib-treated white patients with RCC... CONCLUSIONS: The rs2858996/rs707889 polymorphisms in the HFE gene may be associated with reversible ALT elevation in pazo-panib-treated patients with RCC. Copyright (c) 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Pazopanib in renal cell carcinoma. [2010.12.15]
Pazopanib is an oral, multitargeted tyrosine kinase inhibitor that has been approved by the U.S. Food and Drug Administration for treatment of patients with advanced renal cell cancer on the basis of a randomized, double-blind, placebo-controlled, phase III trial, which showed that once a day dosing of 800 mg of pazopanib resulted in progression free survival of 9.2 months versus 4.2 months (P < 0.0001)...
A phase I study of the pharmacokinetic and safety profiles of oral pazopanib with a high-fat or low-fat meal in patients with advanced solid tumors. [2010.12]
Pazopanib is an oral angiogenesis inhibitor of vascular endothelial growth factor (VEGF) receptor, platelet-derived growth factor receptor, and cytokine receptor. This open-label, randomized, crossover, phase I study evaluated the effect of low- and high-fat meals on the pharmacokinetics (PK) of pazopanib in patients with advanced solid tumors...
Pazopanib: in advanced renal cell carcinoma. [2010.10.01]
Pazopanib is an orally administered, multi-tyrosine kinase inhibitor that interrupts tumor growth in renal cell carcinoma. In a randomized, double-blind, placebo-controlled, multinational trial in patients with locally advanced or metastatic renal cell carcinoma, the median progression-free survival (PFS) of patients who were treated with pazopanib 800 mg once daily was significantly longer than that of placebo recipients (9.2 vs 4.2 months; hazard ratio 0.46 [95% CI 0.34, 0.62])...
Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. [2010.08.01]
PURPOSE: Pazopanib and lapatinib are tyrosine kinase inhibitors that target vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-Kit or epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2/neu), respectively. In cervical cancer, EGFR and HER2/neu overexpression and high microvascular density correlate with survival... CONCLUSION: This study confirms the activity of antiangiogenesis agents in advanced and recurrent cervical cancer and demonstrates the benefit of pazopanib based on the prolonged PFS and favorable toxicity profile.
Clinical Trials Related to Votrient (Pazopanib)
Temsirolimus and Pazopanib in Patients With Advanced Solid Tumors [Recruiting]
The purpose of this study is to test the safety of temsirolimus and pazopanib at different
doses. Patients who have an advanced cancer that is not felt to benefit from standard
treatment or are no longer responding to other treatment will be asked to take part in this
study. The study hypothesis is that temsirolimus and pazopanib can be administered safely in
combination and that combined targeting of the mammalian target of rapamycin (mTOR) and
vascular endothelial growth factor receptor (VEGFR) signaling pathways will be effective in
treating patients with advanced solid tumors.
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer [Recruiting]
The double blind part of the study is being conducted to compare the efficacy and safety of
pazopanib in combination with lapatinib with that of lapatinib alone in subjects with
inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an
Open-label pazopanib arm to this study designed to test whether pazopanib given alone and
lapatinib given alone would be safe and effective to treat patients with inflammatory breast
A Phase I, Open-label, Study of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors [Recruiting]
This is an open-label, four-arm, Phase I, dose escalation study to evaluate the safety and
tolerability and to determine the optimal tolerated regimen (OTR) of pazopanib in
combination with epirubicin or doxorubicin in patients with advanced solid tumors. Patients
will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or
doxorubicin. Dose escalation schemas for each study arm are described in the protocol. For
each arm, the OTR will be defined as the highest dose combination of the agents where no
more than one out of six patients experiences a dose-limiting toxicity. Six to twelve
additional patients in each arm will be studied with the OTR to evaluate toxicity and
pharmacokinetics. This will allow an assessment of potential drug-drug interactions.
Antitumor activity will be assessed using RECIST criteria.
Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer [Recruiting]
This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in
patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received
no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible
patients will be stratified based on the ECOG performance status (0 vs. 1) and number of
metastatic sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods
of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will
receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The
primary objective of the study is to assess how the tolerability and safety differences
between pazopanib and sunitinib translate into patient preference, defined by the patient's
stated preference for which drug they may prefer to continue treatment with at end of study.
The secondary objectives are to evaluate the reason for patient preference as assessed by a
patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and
quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to
dose modification; and to evaluate safety.
VEG113971: An Open-Label Study of the Effects of Ketoconazole or Esomeprazole on Pazopanib PK [Recruiting]
The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or
esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also
test for safety of pazopanib when administered with ketoconazole or esomeprazole.
Reports of Suspected Votrient (Pazopanib) Side Effects
Decreased Appetite (52),
Drug Ineffective (48),
Blood Pressure Increased (36), more >>
Page last updated: 2011-12-09