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

Phase 1

Conditions: metastatic renal cell carcinoma
MedDRA version: 14.1Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 100000004864
MedDRA version: 14.1Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864
MedDRA version: 14.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-001730-33-DE

Lead Sponsor: AVEO PHARMACEUTICALS, INC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 58

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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare subject treatment preference of tivozanib versus sunitinib;Secondary Objective: To compare overall safety and tolerability in subjects treated with<br>tivozanib and sunitinib.<br>To assess the frequency of dose modifications in subjects treated with<br>tivozanib and sunitinib.<br>To evaluate the Quality of Life (QoL) (including kidney-specific<br>symptoms and fatigue) in subjects treated with tivozanib and sunitinib.;Primary end point(s): Proportion of subjects who prefer tivozanib hydrochloride or sunitinib;Timepoint(s) of evaluation of this end point: up to 25 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): safety and tolerability during the course of the study;Timepoint(s) of evaluation of this end point: up to 25 weeks

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