Status:
COMPLETED
Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a randomized, open-label, parallel group Phase III non inferiority study to evaluate the efficacy and safety of pazopanib compared with sunitinib in subjects with advanced renal cell carcinom...
Detailed Description
Approximately 876 eligible subjects (approximately 438 per treatment arm) were planned to be enrolled over the course of the study. However, due to higher than expected withdrawal rates and discordanc...
Eligibility Criteria
Inclusion
- Written informed consent
- Diagnosis of renal cell carcinoma with clear-cell component histology.
- Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC
- Locally advanced or metastatic renal cell carcinoma
- Measurable disease by CT or MRI
- Karnofsky performance scale status of \>=70
- Age \>=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 \<12.0mg/dL
- Left ventricular ejection fraction \>= lower limit of institutional normal.
Exclusion
- 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 \>=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, known intraluminal metastatic lesion/s with suspected bleeding, 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) \> 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, coronary artery by-pass graft surgery, 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 within the past 12 months
- 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 \>=150mmHg or diastolic blood pressure of \>=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/coughing up blood within 6 weeks of first dose of study drug
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- 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.
- Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc).
- Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)
- Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib.
Key Trial Info
Start Date :
August 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2021
Estimated Enrollment :
1110 Patients enrolled
Trial Details
Trial ID
NCT00720941
Start Date
August 14 2008
End Date
March 24 2021
Last Update
March 30 2025
Active Locations (227)
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1
Novartis Investigative Site
Huntsville, Alabama, United States, 35805
2
Novartis Investigative Site
Tucson, Arizona, United States, 85710
3
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
4
Novartis Investigative Site
Beverly Hills, California, United States, 90211