A study of pazopanib versus sunitinib in the treatment of subjects with locally advanced and/or metastatic renal cell carcinoma
- Conditions
- ocally Advanced and/or Metastatic Renal Cell CarcinomaLocally Advanced and/or Metastatic Renal Cell CarcinomaCancer - Kidney
- Registration Number
- ACTRN12609000392268
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 876
Written informed consent
Diagnosis of renal cell carcinoma with clear-cell component histology.
Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mammalian target of Rapamycin (mTOR) inhibitor, sunitinib, sorafenib or other Vascular endothelial growth factor (VEGF) Tyrosine Kinase Inhibitor (TKI) for advanced or metastatic Renal Cell Carcinoma (RCC)
Locally advanced or metastatic renal cell carcinoma
Measurable disease by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
Karnofsky performance scale status of
Age greater than or equal to 18 years
A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.
Adequate organ system function
Total serum calcium concentration less than 12.0mg/dL
Left ventricular ejection fraction greater than or equal to lower limit of institutional normal.
Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)
History of another malignancy (unless have been disease-free for 3 years)
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 greater than or equal to 6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
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.
Presence of uncontrolled infection.
Prolongation of corrected QT interval (QTc) greater than 480 milliseconds
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
History of cerebrovascular accident including transient ischemic attack
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)
Poorly controlled hypertension (defined as systolic blood pressure of greater than or equal to 150mmHg or diastolic blood pressure of greater than or equal to 90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
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.
Evidence of active bleeding or bleeding susceptibility
Spitting up blood within 6 weeks of first dose of study drug
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.
Use any prohibited medications within 14 days of the first dose of study medication.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival assessed by radiologic assessment.[Assessed every 6 weeks up to week 24 then 12 weekly thereafter.]
- Secondary Outcome Measures
Name Time Method Safety as assessed by adverse event reporting[Assessed at every visit.];Quality of life as assessed by Cancer Therapy Satisfaction Questionnaire and Functional Assessment of Chronic Illness Therapy[Administered at baseline and every cycle of treatment.];Objective Tumour Response Rate as assessed by Response Evaulation Criteria In Solid Tumours (RECIST).[Assessed every 6 weeks up to week 24 then 12 weekly thereafter.];Overall Survival[Assessed at every visit.]