Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Measuring Effects of Pazopanib Hydrochloride in Patients With Metastatic Kidney Cancer

Exclusion Criteria

• •Prior malignancy; Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
• •History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug; screening with CNS imaging studies (computed tomography \[CT\] or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases
• •Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
• •* Active peptic ulcer disease
• •* Known intraluminal metastatic lesion/s with risk of bleeding
• •* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
• •* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
• •Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• •Malabsorption syndrome
• •Major resection of the stomach or small bowel
• •* Presence of uncontrolled infection
• •* Corrected QT interval (QTc) \> 480 msecs using Bazett's formula
• •* History of any one or more of the following cardiovascular conditions within the past 6 months:
• •Cardiac angioplasty or stenting
• •Myocardial infarction
• •Unstable angina
• •Coronary artery bypass graft surgery
• •Symptomatic peripheral vascular disease
• •* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
• •* Poorly controlled hypertension (defined as systolic blood pressure (SBP) of \>= 140 mmHg or diastolic blood pressure \[DBP\] of \>= 90 mmHg); Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be \< 140/90 mmHg in order for a subject to be eligible for the study
• •* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
• •* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
• •* Evidence of active bleeding or bleeding diathesis
• •* Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
• •* Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug
• •* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
• •* Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
• •* Treatment with any of the following therapies:
• •Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
• •Anti-cancer chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
• •Any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
• •* Any ongoing toxicity from prior anti-cancer therapy that is \> grade 1 and/or that is progressing in severity, except alopecia