EUCTR2007-005083-28-PL进行中（未招募）不适用
A Phase II, Randomized, Open-label, MultiCenter, Study Evaluating the Efficacy of SOrafenib AloNe and Sorafenib in Combination with Low DosE InterfeRon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients with Metastatic Renal Cell Carcinoma (RCC) - CONCERT
Bayer Healthcare AG, D-51368, Leverkusen, Germany0 个研究点目标入组 120 人开始时间: 2008年5月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •Disease progression as defined by RECIST criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
- •And/or patients who have discontinued sunitinib treatment at any point due to toxicity
- •Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
- •MSKCC prognostic score low or intermediate
- •ECOG Performance Status of 0 or1
- •Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%)
- •Age = 18 years
- •Life expectancy of at least 12 weeks
- •Patients with at least one measurable lesion. Lesions must be measured by CT-scan or MRI (Magnetic Resonance Imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST, see Protocol Appendix 10.5 for detail)
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •Hemoglobin = 9.0 g/dl
- •Absolute neutrophil count (ANC) =1,500/mm3
- •Platelet count = 100,000/µl
- •Total bilirubin = 1.5 times the upper limit of normal
- •ALT and AST = 2.5 x upper limit of normal (=5 x upper limit of normal for patients with liver involvement of their cancer)
- •Alkaline phosphatase < 4 x ULN
- •PT or INR and PTT < 1.5 x upper limit of normal (patients who receive anti-coagulation treatment with an agent such as coumarin derivates or heparin will be allowed to participate. For patients on coumarin derivates , close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care).
- •Serum creatinine = 2.0 x upper limit of normal.
- •Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
- •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
- •Patient should be excluded if they have unresolved chronic toxicity grade > 1 and related to prior therapy with sunitinib.
- •History of cardiac disease:
- •oCongestive heart failure NYHA (New York Heart Association) class > 2
- •oActive CAD (Coronary artery disease) or MI (Myocardial Infarction) more than 6 months prior to study entry is allowed)
- •oCardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- •oUncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- •Known history of HIV (Human immunodeficiency virus) infection or chronic Hepatitis B or C
- •Active clinically serious infections (grade > 2 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 3.0))
- •Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative brain imaging study within
- •4 weeks of study entry and is clinically stable , with respect to CNS metastases, at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
- •History of organ allograft
- •Patients with evidence or history of bleeding diathesis or coagulopathy
- •Patients undergoing renal dialysis
- •Previous or concurrent cancer that is distinct in primary site or histology form the renal cell carcinoma EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors [Ta (Noninvasive tumor), Tis (Carcinoma in situ) & T1 (Tumor invades lamina propria)] or any cancer curatively treated > 3 years prior to study entry
- •Any hemorrhage/bleeding event grade = 3 within 4 weeks of first dose of study drug
- •Serious, non-healing wound, ulcer, or bone fracture
- •Pregnant or breast-feeding patients. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial. The investigator is requested to advise the patient how to achieve an adequate contraception.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •Patients unable to swallow oral medications
- •Any malabsorption condition
- •Excluded therapies and medications, previous and concomitant:
- •Any anticancer therapy during the study
- •Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed as described in the Prior and concomitant Therapy section)
- •Major surgery, or significant traumatic injury within 4 weeks of the first dose of study drug
- •Autologous bone marrow transplant or stem cell rescue
- •Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •Use of biologic response modifiers, such as
研究者
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