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A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC (TAURUS)

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tivozanib
Sunitinib
Sponsored by
AVEO Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring Tivozanib hydrochloride, renal cell carcinoma, subject preference, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tivozanib Hydrochloride

Sunitinib

Arm Description

1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks.

50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks.

Outcomes

Primary Outcome Measures

Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Secondary Outcome Measures

Number of Subjects With AEs and SAEs
Number of subjects with serious and non-serious adverse events.
Number of Subjects With Dose Reductions
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Dose Interruptions
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Hematology Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Chemistry Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Coagulation Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Urinalysis Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Thyroid Function Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Full Information

First Posted
August 23, 2012
Last Updated
October 5, 2020
Sponsor
AVEO Pharmaceuticals, Inc.
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01673386
Brief Title
A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
Acronym
TAURUS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AVEO Pharmaceuticals, Inc.
Collaborators
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
Tivozanib hydrochloride, renal cell carcinoma, subject preference, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tivozanib Hydrochloride
Arm Type
Experimental
Arm Description
1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks.
Arm Title
Sunitinib
Arm Type
Active Comparator
Arm Description
50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Tivozanib
Other Intervention Name(s)
Tivozanib Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent
Primary Outcome Measure Information:
Title
Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Up to 25 weeks
Secondary Outcome Measure Information:
Title
Number of Subjects With AEs and SAEs
Description
Number of subjects with serious and non-serious adverse events.
Time Frame
Up to 25 weeks
Title
Number of Subjects With Dose Reductions
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Up to 25 weeks
Title
Number of Subjects With Dose Interruptions
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Up to 25 weeks
Title
Number of Subjects With Grade 3/4 Hematology Abnormalities
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Up to 25 weeks
Title
Number of Subjects With Grade 3/4 Chemistry Abnormalities
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Up to 25 weeks
Title
Number of Subjects With Grade 3/4 Coagulation Abnormalities
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Up to 25 weeks
Title
Number of Subjects With Grade 3/4 Urinalysis Abnormalities
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Up to 25 weeks
Title
Number of Subjects With Grade 3/4 Thyroid Function Abnormalities
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Up to 25 weeks
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Title
Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Title
Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Title
Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)
Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame
Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Needle, MD
Organizational Affiliation
AVEO Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90001
Country
United States
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30301
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46077
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01601
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55111
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43004
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53558
Country
United States
City
Antwerp
Country
Belgium
City
Brussels
Country
Belgium
City
Bordeaux
Country
France
City
Caen
Country
France
City
Lyon
Country
France
City
Paris
Country
France
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Heidelberg
Country
Germany
City
Munich
Country
Germany
City
Aviano
Country
Italy
City
Pavia
Country
Italy
City
Rome
Country
Italy
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Pamplona
Country
Spain
City
Valencia
Country
Spain
City
Glasgow
State/Province
Scotland
Country
United Kingdom
City
Swansea
State/Province
Wales
Country
United Kingdom
City
Cambridge
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.aveooncology.com/
Description
Aveo Pharmaceuticals, Inc. official web page

Learn more about this trial

A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC

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