NL-OMON43677已完成3 期
Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib followed by sorafenib in the treatment of advanced / metastatic renal cell carcinoma - SWITCH 2 Study
Dekan der Fakultät für Medizin der Technischen Universität München0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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
- •1. Patients with metastatic / advanced RCC (all histologies), who are not suitable
- •for cytokine therapy and for whom study medication constitutes first-line
- •treatment. For cytokine-unsuitability at least one of the following criteria must be
- •fulfilled*:
- •* Age 66 to 88 years
- •* Non-clear cell histology RCC
- •* Intermediate risk according to MSKCC score
- •* ECOG * 1 and> 1 organ metastasis + < 24 months between diagnosis and
- •establishing indication for interleukin-2-therapy
- •* ECOG * 1 and *unable to carry on normal activity or do active work*
- •(Karnofsky Index 70%)
- •* Creatinine * 1x ULN and < 2x ULN
- •* Total bilirubin * 1x ULN and < 1.5x ULN
- •* Present autoimmune disease
- •* Patients who might require steroids
- •* Hypersensitivity against cytokines
- •* Severe organic disease, not interfering with other in-/exclusion criteria of the
- •Switch-2 study
- •* Non-symptomatic brain metastases
- •* Severe lung disease (e.g. PAH, COPD) with Pa O2 < 60 mmHg on rest
- •2. Age * 18 and * 85 years
- •3. Karnofsky Index * 70% (see appendix *15.1 Performance Status (ECOG,
- •Karnofsky)*)
- •4. MSKCC prognostic score (2004), low or intermediate (see appendix *15.2
- •Motzer Scoring*)
- •5. Life expectancy of at least 12 weeks
- •6. Subjects with at least one uni-dimensional (for RECIST 1.1, see appendix *15.3
- •RECIST 1.1) measurable lesion. Lesions must be measured by CT/MRI-scan
- •7. Adequate bone marrow, liver and renal function as assessed by the following
- •laboratory requirements to be conducted within 7 days prior to start of therapy:
- •* Hemoglobin > 9.0 g/dl
- •* Absolute neutrophil count (ANC) >1,500/*l
- •* Platelet count * 100,000/*l
- •* Total bilirubin < 1.5x the upper limit of normal (Note: Subjects with Gilbert*s
- •Syndrome are eligible if their total bilirubin is <3.0 X ULN and direct bilirubin
- •is * 35%.)
- •* ALAT and ASAT < 2.5x upper limit of normal (Note: concomitant elevations in
- •bilirubin and ASAT/ALAT above 1.0x upper limit of normal are not permitted).
- •* Alkaline phosphatase < 4x upper limit of normal
- •* PT-INR/aPTT < 1.2x upper limit of normal [Patients who are being
- •therapeutically anticoagulated with an agent such as coumadin or heparin will
- •be allowed to participate provided that their INR is stable and within the
- •recommended range for the desired level of anticoagulation and no prior
- •evidence of underlying abnormality in these parameters exists.]
- •* Serum creatinine < 2 x upper limit of normal
- •8. Written Informed Consent
- •_____________________________________________________________________
- •*Based on references:
- •o Kirchner H., H. Heinzer, J. Roigas und F. Overkamp: Differentialtherapie beim
- •metastasierenden Nierenzellkarzinom. Der Onkologe 2008; 14: 191-197;
- 另有 2 项未显示
排除标准
- •1. History of cardiac disease: congestive heart failure >NYHA class 2 or with LVEF at
- •baseline echocardiography < 50% (echocardiography is optional); active CAD (MI
- •more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring
- •anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- •2. Uncontrolled hypertension (defined as blood pressure * 150 mmHg systolic and/or
- •* 90 mmHg diastolic on medication).
- •3. History of HIV infection or chronic hepatitis B or C
- •4. Active clinically serious infections (> grade 2 NCI-CTC version 4.03)
- •5. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6
- •months from definitive therapy, has a negative imaging study within 4 weeks of
- •study entry and is clinically stable with respect to the tumor at the time of study
- •6. Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
- •7. Patients with evidence or history of bleeding diathesis
- •8. History of organ allograft
- •9. Major surgery within 4 weeks of start of study
- •10. Autologous bone marrow transplant or stem cell rescue within 4 months before
- •study start.
- •11. Any significant condition that increases the risk for bleeding, including, but not
- •limited to active peptic ulcer disease, inflammatory bowel disease, known
- •intraluminal or endobronchial metastatic lesions and/or lesions infiltrating major
- •pulmonary vessels with risk of bleeding, presence of non-healing wound or trauma
- •within 4 weeks prior to first dose of investigational drug
- •12. History of cerebrovascular accident including transient ischemic attack (TIA),
- •pulmonary embolism or untreated deep vein thrombosis (DVT) within the past 6
- •months (Note: Subjects with recent DVT who have been treated with therapeutic
- •anti-coagulating agents for at least 6 weeks are eligible)
- •13. Corrected QT Interval (QTc) > 480 msecs
- •14. Untreated hypothyroidism
- •15. Patients undergoing renal dialysis
- •16. Previous or concurrent cancer that is distinct in primary site or histology from the
- •cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated
- •basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer
- •curatively treated > 3 years prior to study entry
- •17. Pregnant or breast-feeding patients. Women of childbearing potential must have a
- •negative pregnancy test performed within 7 days of the start of treatment. Both
- •men and women enrolled in this trial must use adequate barrier birth control
- •measures (with a Pearl Index < 1) during the course of the trial and 3 months after
- •the completion of trial.
- •18. Substance abuse, medical, psychological or social conditions that may interfere
- •with the patient*s participation in the study or evaluation of the study results
- •19. Any condition that is unstable or could jeopardize the safety of the patient and their
- •compliance in the study
- •20. Patients unable to swallow oral medications
- •21. Clinically significant gastrointestinal abnormalities that may affect absorption of
- •investigational product
- •22. Known allergy to Votrient® or Nexavar®(i.e. to active substance or one of the
- •constituents)
- •23. Prior exposure to study drugs.
- •24. Investigational drug therapy within 4 weeks of study entry.
- •25. Use of biologic response modifiers, such as G-CSF and other hematopoietic
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