EUCTR2008-005053-38-GB进行中（未招募）不适用
An open-label study to investigate the pharmacodynamics of a repeat dose regimen of bevacizumab (10mg/kg q2w) and escalating repeat doses of pazopanib in renal cell carcinoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed unresectable RCC with a clear cell component.
- •2. Experienced documented evidence of radiological progression based on [RECIST] while on first line (or greater) RCC therapy and within 6 months prior to the first dose of study medication (bevacizumab).
- •3. Evidence of unidimensionally measurable disease.
- •4. Free of any malignant disease other than RCC for at least 5 years prior to the first dose of (bevacizumab) in this study, with the exception of the following: Cervical carcinoma in situ, Melanoma in situ,Basal or squamous cell carcinoma of the skin
- •5. ECOG Performance Status of 0 to 1.
- •6. Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedures to NCI CTCAE Grade 1 or less.
- •7. Adequate organ function, as defined by the protocol.
- •8. Males and females = 18 years of age at screening.
- •1. The subject met all eligibility criteria in Part I of the study.
- •2. The subject would derive continued therapeutic benefit from anti-angiogenic therapy.
- •3. There are no safety concerns that would present an unacceptable benefit-risk profile for treatment with pazopanib.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Cancer metastatic to the central nervous system or leptomeningeal carcinomatosis.
- •2. Previous treatment with bevacizumab or pazopanib.
- •3. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bevacizumab or pazopanib or components of bevacizumab or pazopanib (other than active drugs).
- •4. Anticancer therapy (radiotherapy, chemotherapy, or immunotherapy) within 28 days prior to the first dose of study medication and through completion of all study procedures.
- •5. Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study medication.
- •6. Assessable disease is unsuitable for biopsy or the patient is unwilling or not sufficiently fit to undergo serial biopsies.
- •7. Major surgical procedure or traumatic injury within 28 days prior to the first dose of study medication (bevacizumab).
- •8. Evidence of active bleeding or bleeding diathesis, or any serious, non-healing wound, ulcer, or bone fracture.
- •9. Hemoptysis within 6 weeks of the first dose of study medication.
- •10. Use of therapeutic doses of warfarin within 5 half-lives of the first dose of study medication and during treatment in the study
- •11. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days of the first dose of study medication.
- •12. Clinically significant gastrointestinal abnormalities.
- •13. Known endobronchial lesions or involvement of large pulmonary vessels by tumor.
- •14. Active or uncontrolled infection at the time of first dose of study medication.
- •15. Prolongation of corrected QT interval (QTc) >480 milliseconds (msec).
- •16. Positive test result for (HIV) antibody.
- •17. Any of the following within 6 months prior to the first dose of study medication (bevacizumab): Cardiac angioplasty or stenting, Severe and/or unstable angina, Myocardial infarction, Coronary artery bypass graft (CABG), Class III or IV congestive heart failure, Symptomatic peripheral vascular disease, Cardiac dysrhythmias of NCI CTCAE Grade 2 or greater and atrial fibrillation of any grade.
- •18. History of cerebrovascular accident or transient ischemic attack
- •19. Poorly controlled hypertension.
- •20. History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •21. Internal metal medical devices or other metal items that may place the subject's health at risk and/or interfere with MRI scans.
- •22. History of hypersensitivity to gadolinium or other intravenous dye contrast agents.
- •23. History of hypersensitivity to iodine-based contrast agents or history of severe asthma.
- •24. Pregnant or lactating females.
- •25. Any serious and/or unstable pre-existing medical, psychiatric, or other condition.
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