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

Conditions: metastatic renal cell carcinoma
MedDRA version: 15.0Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 100000004864
MedDRA version: 15.0Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864
MedDRA version: 15.0Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-001730-33-IT

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. = 18 year old males or females 2. Subjects with unresectable mRCC 3. Histologically or cytologically confirmed RCC of any histology 4. Subjects with or without prior nephrectomy 5. Evaluable disease per RECIST Version 1.1 (see Appendix A). 6. ECOG performance status of 0 or 1 (see Appendix B) 7. A female is eligible to participate if she is of non-childbearing potential or has documentation of a negative pregnancy test prior to the start of the study treatment. Sexually active pre-menopausal female subjects (and male subjects whose sexual partners are of childbearing potential) must agree to use adequate, highly effective contraceptive measures, while on study and for 45 days after the last dose of last study drug. Effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable or injectable contraceptives plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). 8. 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: 0
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 for treatment of mRCC 2.Central nervous system metastases. 3.Any of the following hematologic and coagulation abnormalities: Hemoglobin < 9.0 g/dL; oAbsolut e neutrophil count (ANC) < 1500 per mm3; Platelet count < 100,000 per mm3. 4.Any of the following serum chemistry and urinalysis abnormalities: oTotal bilirubin > 1.5 × ULN (or > 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome) oAspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN (or > 5 × ULN for subjects with liver metastasis); oAlkaline phosphatase > 2.5 × ULN (or > 5 × ULN for subjects with liver or bone metastasis); oCreatinine > 2.0 × ULN; oProteinuria > 3+ by urinalysis or urine dipstick. 5.Significant cardiovascular disease, 6.Non-healing wound, bone fracture, or skin ulcer. 7.Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug. 8.Serious/active infection or infection requiring parenteral antibiotics. 9.Corrected QT interval (QTc) of >480 msec using Bazett’s formula. 10.Radiotherapy or minor surgical procedure within 2 weeks, or major surgical procedure within 4 weeks prior to administration of first dose of study drug; inadequate recovery from prior surgical procedure. 11.Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug. 12 Significant bleeding disorders within 6 months prior to administration of first dose of study drug 13.Currently active second primary malignancy, including hematologic malignancies (leukemia, lymphoma, multiple myeloma, etc.), other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Subjects are considered to have a currently active malignancy if they have completed anti-cancer therapy and have not been disease free for > 2 years. 14.Pregnant or lactating females. 15.History of genetic or acquired immune suppression disease such as human immunodeficiency virus (HIV); subjects on immune suppressive therapy for organ transplant. 16.Life-threatening illness or organ system dysfunction compromising safety evaluation. 17.Requirement for hemodialysis or peritoneal dialysis. 18.Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure. 19.Known hypersensitivity to drugs chemically related to tivozanib hydrochloride or sunitinib or their excipients. 20.Psychiatric disorder or altered mental status precluding informed consent or protocol related testing

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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