EUCTR2012-001730-33-BEActive, not recruitingPhase 1
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
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AVEO PHARMACEUTICALS, INC
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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