NL-OMON39600已完成2 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: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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 cancer.;- Adequate organ system function.;- A female is eligible to enter and participate in this study if she is of: Non-childbearing potential (physiologically or by using adequate contraception) .
排除标准
- •- Malignancy within the previous 5 years.;- 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 nonhealing 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.;- 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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