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Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma
Basic Trial Information
Summary This study is being conducted to provide a direct comparison of the efficacy, safety and tolerability for pazopanib and sunitinib (SUTENT) Eligibility Criteria Inclusion Criteria: 1. Written informed consent 2. Diagnosis of renal cell carcinoma with clear-cell component histology. 3. Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC 4. Locally advanced or metastatic renal cell carcinoma 5. Measurable disease by CT or MRI 6. Karnofsky performance scale status of >=70 7. Age >=18 years 8. A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception. 9. Adequate organ system function 10. Total serum calcium concentration <12.0mg/dL 11. Left ventricular ejection fraction >= lower limit of institutional normal. Exclusion Criteria: 1. Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study) 2. History of another malignancy (unless have been disease-free for 3 years) 3. History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants) 4. Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, Inflammatory bowel disease, ulcerative colitis, 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. 5. Presence of uncontrolled infection. 6. Prolongation of corrected QT interval (QTc) > 480 milliseconds 7. History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association 8. History of cerebrovascular accident including transient ischemic attack 9. History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks) 10. Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry 11. 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. 12. Evidence of active bleeding or bleeding susceptibility 13. Spitting up blood within 6 weeks of first dose of study drug 14. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study. 15. Use any prohibited medications within 14 days of the first dose of study medication. 16. Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug. Trial Lead Organizations/Sponsors GlaxoSmithkline
Trial Sites
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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