A PHASE 2 RANDOMIZED, DOUBLE-BLIND, CROSSOVER, CONTROLLED, MULTI-CENTER, SUBJECT PREFERENCE STUDY OF TIVOZANIB HYDROCHLORIDE VERSUS SUNITINIB IN THE TREATMENT OF SUBJECTS WITH METASTATIC RENAL CELL CARCINOMA

AVEO PHARMACEUTICALS, INC0 个研究点目标入组 160 人开始时间: 2012年11月14日最近更新: 2014年3月10日

试验速览

暂无简介。

•1.Subjects with unresectable mRCC
•2.Histologically or cytologically confirmed RCC of any histology
•3.Subjects with or without prior nephrectomy
•Version 1.1 (see Appendix A).
•4.ECOG performance status of 0 or 1 (see Appendix B)
•5.Ability to give written informed consent and comply with protocol requirements, including drug treatments and follow-up 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 96
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 64

•1.Any prior systemic therapy (including interleukin-2, interferon-alpha, chemotherapy, bevacizumab, nvestigational or licensed drug that targets vascular endothelial growth factor [VEGF] or VEGF receptors/pathway or are mammalian target of rapamycin [mTOR] inhibitors) for treatment of mRCC
•2.Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders
•3. Significant serum chemistry or urinalysis abnormalities.
•4. Significant cardiovascular disease, including:
•Symptomatic Left Ventricular Dysfunction or baseline left ventricular ejection fraction (LVEF) of <= lower limit of institutional normal (LLN) ; uncontrolled hypertension; myocardial infarction; severe angina. or unstable angina within 6 months prior to administration of first dose of study drug.
•History of Class III or IV congestive heart failure
•History of serious ventricular arrhythmia
•Cardiac arrhythmias
•Coronary or peripheral artery bypass graft within 6 months of screening.
•5.Corrected QT interval (QTc) of > 480 msec using Bazett’s formula.
•6. Currently active second primary malignancy

发起方