EUCTR2011-000127-32-NL进行中（未招募）1 期
A randomized phase II study to explore the efficacy and feasibility of upfront bi-monthly rotations between Everolimus and Pazopanib with sequential treatment of first line Pazopanib and second line Everolimus until progression in patients with advanced or metastatic clear cell renal cancer. - ROPETAR
Werkgroep Immunotherapie Nederland voor Oncologie0 个研究点目标入组 100 人开始时间: 2014年1月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up.
- •- Age = 18 years.
- •- Histologically confirmed diagnosis of progressive metastatic clear cell renal cell cancer defined as >10% of the tumor cells having the clear cell phenotype.
- •- Locally advanced (defined as disease not amenable to curative surgery or
- •radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to
- •AJCC staging
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- •- Measurable disease.
- •- No prior systemic anti-cancer treatment against clear cell renal cell cancer.
- •- Adequate organ system function.
- •- Non-childbearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Prior malignancy.
- •- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.
- •- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- •1)Active peptic ulcer disease.
- •2)Known intraluminal metastatic lesions with risk of bleeding.
- •3) Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation.
- •4)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:
- •1)Malabsorption syndrome.
- •2)Major resection of the stomach or small bowel.
- •-Presence of uncontrolled infection.
- •-Known past or present infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV).
- •-Corrected QT interval (QTc) > 480 msecs using Bazett’s formula.
- •-History of one or more of the following cardiovascular conditions within the past 6 months:
- •1)Cardiac angioplasty or stenting
- •2)Myocardial infarction
- •3)Stable or unstable angina pectoris.
- •4)Coronary artery bypass graft surgery.
- •5)Symptomatic peripheral vascular disease
- •6)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 =160 mmHg or diastolic blood pressure (DBP) of = 90mmHg].
- •- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •- 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 or modify the dosing of interacting drugs as listed in Section 6.8.1. and 6.8.2 of the protocol 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.
- •- Pregnant or lactating female.
- •- Treatment with any of the following anti-cancer therapies: Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of Pazopanib OR
- •Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy.
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