EUCTR2009-009516-44-HU进行中（未招募）1 期
A randomised, open label, parallel group Phase II study comparing theefficacy and tolerability of BIBF 1120 versus sunitinib in previouslyuntreated patients with Renal Cell Cancer. - BIBF 1120 in 1st line Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment.
- •Histological-confirmed diagnosis of renal cell cancer with clear cell
- •Age = 18 years.
- •ECOG Performance Score 0 or 1.
- •Life expectancy of at least 3 months
- •Must have measurable disease according to RECIST, i.e. presence of at
- •least one target lesion according to RECIST criteria in a previously
- •non-irradiated area
- •Serum creatinine < 2 x ULN.
- •Written informed consent consistent with ICH-GCP guidelines.
- •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
- •Serious illness or concomitant non-oncological disease such as neurologic,
- •psychiatric, infectious disease or active ulcers (gastro-intestinal tract,
- •skin) or laboratory abnormality that may increase the risk associated with
- •study participation or study drug administration and in the judgment of
- •the investigator would make the patient inappropriate for entry into the
- •Major injuries, bone fracture and/or surgery within past 4 weeks or/ and
- •planned surgical procedures during the study period.
- •Hypersensitivity to BIBF 1120, sunitinib or the excipients of the study
- •Significant cardiovascular diseases (i.e. uncontrolled hypertension,
- •unstable angina, history of infarction within past 12 months, congestive
- •heart failure > NYHA II, serious cardiac arrhythmia).
- •LV-EF (left ventricular ejection fraction) by ECHO or MUGA below local
- •limits of normal.
- •Hepatic function: total bilirubin outside of normal limits; ALT and
- •AST > 1.5x upper limit of normal (ULN) in patients without liver metastasis.
- •For patients with liver metastasis: total bilirubin outside of normal
- •limits, ALT and AST > 2.5x ULN.
- •Coagulation parameters: international normalised ratio (INR) > 2,
- •prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of
- •deviation of institutional ULN.
- •Absolute neutrophil count (ANC) < 1500/ml, Platelets <100000/ml,
- •Haemoglobin <9.0 g/dl.
- •History of clinically significant haemorrhagic or thromboembolic event in
- •the past 6 months.
- •Known inherited predisposition to bleeds or to thrombosis.
- •History of clinically significant haemoptysis within the last 3 months (more
- •than one tea-spoon of fresh blood per day)
- •Therapeutic anticoagulation (except low-dose heparin and/or heparin flush
- •as needed for maintenance of an in-dwelling intravenous device) or antiplatelet
- •therapy (except for low-dose therapy with acetylsalicylic acid
- •< 325mg per day).
- •Previous treatment for RCC with targeted agents (in particular including
- •any antibody and any VEGF/VEGFR, EGFR and mTOR inhibitors),
- •immunotherapy [Interferon (IFNa) or Interleukin-2 (IL-2)] or chemotherapy.
- •Treatment with other investigational drugs or participation in another
- •clinical study within the past 4 weeks before start of therapy or
- •concomitantly with this study.
- •Patients unable to comply with the protocol.
- •Pregnancy or breast feeding.
- •Active alcohol or drug abuse.
- •Women of child bearing potential, or men who are able to father a child,
- •unwilling to use a medically acceptable form of contraception during the
- •study period.
- •Symptomatic central nervous system (CNS) metastatis or leptomeningeal
- •disease as documented by CT, MRI or analysis of cerebrospinal fluid
- •requiring radiotherapy, steroids or anticonvulsive treatment.
- •Radiotherapy within the previous 4 weeks.
- •QTcF interval > 500 ms at screening
研究者
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