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: 15.0Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 15.0Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 15.0Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-001730-33-BE

Lead Sponsor: AVEO PHARMACEUTICALS, INC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

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