A Subject Treatment Preference Study of Tivozanib Hydrochloride Versus Sunitinib in Subjects With Metastatic Renal Cell Carcinoma

Status:	Completed
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/27/2013
Start Date:	July 2012
End Date:	January 2014
Contact:	Philip Komarnitsky, MD
Email:	pkomarnitsky@aveooncology.com
Phone:	617-299-5654

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

This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride
and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy
for Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG
score (0 vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1
to 1 of 2 treatment arms. The study consists of two 12-week treatment periods with a
1-week washout in between. Subjects will receive double-blind (over-encapsulated) tivozanib
hydrochloride and sunitinib sequentially. The study is designed to compare subject
treatment preference, as well as overall safety and tolerability, frequency of dose
modifications and kidney-specific health outcomes/QoL.

Inclusion Criteria:

- Unresectable mRCC

- Histologically or cytologically confirmed RCC of any histology

- Subjects with or without prior nephrectomy

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

- Any prior systemic therapy for treatment of mRCC (including investigational or
licensed drugs that target VEGF or VEGF receptors/pathway, or are mammalian target of
rapamycin [mTOR] inhibitors)

- Central nervous system malignancies or metastases

- Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or
coagulation disorders

- Significant serum chemistry or urinalysis abnormalities

- Significant cardiovascular disease, including symptomatic left ventricular ejection
fraction or baseline LVEF of ≤ institutional lower limit of normal, uncontrolled
hypertension, myocardial infarction or severe angina within 6 months prior to
administration of first dose of study drug, history of class III or IV congestive
heart failure, or history of serious ventricular arrhythmia, cardiac arrhythmias, or
coronary or peripheral bypass graft within 6 months of screening

- Corrected QT interval (QTc) of >480 msec using Bazett's formula

- Currently active second primary malignancy

We found this trial at

sites

Clinical Trial Facility in Indianapolis Indiana

Indianapolis, Indiana 46202

from

Indianapolis, IN