Terminated
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
Led by AVEO Pharmaceuticals, Inc. · Updated on 2020-10-27
58
Participants Needed
38
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AVEO Pharmaceuticals, Inc.
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Brief Title
A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
Trial Site Locations
Total: 38 locations
1
Los Angeles, California, United States, 90001
Status Unknown
2
Albany, Georgia, United States, 31701
Status Unknown
3
Atlanta, Georgia, United States, 30301
Status Unknown
4
Chicago, Illinois, United States, 60007
Status Unknown
5
Indianapolis, Indiana, United States, 46077
Status Unknown
6
Shreveport, Louisiana, United States, 71101
Status Unknown
7
Worcester, Massachusetts, United States, 01601
Status Unknown
8
Minneapolis, Minnesota, United States, 55111
Status Unknown
9
New York, New York, United States, 10001
Status Unknown
10
Columbus, Ohio, United States, 43004
Status Unknown
11
Portland, Oregon, United States, 97035
Status Unknown
12
Charleston, South Carolina, United States, 29401
Status Unknown
13
Myrtle Beach, South Carolina, United States, 29572
Status Unknown
14
San Antonio, Texas, United States, 78006
Status Unknown
15
Madison, Wisconsin, United States, 53558
Status Unknown
16
Antwerp, Belgium
Status Unknown
17
Brussels, Belgium
Status Unknown
18
Bordeaux, France
Status Unknown
19
Caen, France
Status Unknown
20
Lyon, France
Status Unknown
21
Paris, France
Status Unknown
22
Berlin, Germany
Status Unknown
23
Hamburg, Germany
Status Unknown
24
Hanover, Germany
Status Unknown
25
Heidelberg, Germany
Status Unknown
26
Munich, Germany
Status Unknown
27
Aviano, Italy
Status Unknown
28
Pavia, Italy
Status Unknown
29
Rome, Italy
Status Unknown
30
Barcelona, Spain
Status Unknown
31
Madrid, Spain
Status Unknown
32
Pamplona, Spain
Status Unknown
33
Valencia, Spain
Status Unknown
34
Glasgow, Scotland, United Kingdom
Status Unknown
35
Swansea, Wales, United Kingdom
Status Unknown
36
Cambridge, United Kingdom
Status Unknown
37
London, United Kingdom
Status Unknown
38
Manchester, United Kingdom
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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