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

October 5, 2020 updated by: AVEO Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
      • Brussels, Belgium
  • France
      • Bordeaux, France
      • Caen, France
      • Lyon, France
      • Paris, France
  • Germany
      • Berlin, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Munich, Germany
  • Italy
      • Aviano, Italy
      • Pavia, Italy
      • Rome, Italy
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Pamplona, Spain
      • Valencia, Spain
  • United Kingdom
      • Cambridge, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom
    • Wales
      • Swansea, Wales, United Kingdom
  • United States
    • California
      • Los Angeles, California, United States, 90001
    • Georgia
      • Albany, Georgia, United States, 31701
      • Atlanta, Georgia, United States, 30301
    • Illinois
      • Chicago, Illinois, United States, 60007
    • Indiana
      • Indianapolis, Indiana, United States, 46077
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
    • Massachusetts
      • Worcester, Massachusetts, United States, 01601
    • Minnesota
      • Minneapolis, Minnesota, United States, 55111
    • New York
      • New York, New York, United States, 10001
    • Ohio
      • Columbus, Ohio, United States, 43004
    • Oregon
      • Portland, Oregon, United States, 97035
    • South Carolina
      • Charleston, South Carolina, United States, 29401
      • Myrtle Beach, South Carolina, United States, 29572
    • Texas
      • San Antonio, Texas, United States, 78006
    • Wisconsin
      • Madison, Wisconsin, United States, 53558

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tivozanib Hydrochloride
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.
Drug: Tivozanib
Other Names:
  • Tivozanib Hydrochloride
ACTIVE_COMPARATOR: Sunitinib
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.
Drug: Sunitinib
Other Names:
  • Sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
Time Frame: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Up to 25 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With AEs and SAEs
Time Frame: Up to 25 weeks
Number of subjects with serious and non-serious adverse events.
Up to 25 weeks
Number of Subjects With Dose Reductions
Time Frame: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Up to 25 weeks
Number of Subjects With Dose Interruptions
Time Frame: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Up to 25 weeks
Number of Subjects With Grade 3/4 Hematology Abnormalities
Time Frame: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Up to 25 weeks
Number of Subjects With Grade 3/4 Chemistry Abnormalities
Time Frame: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Up to 25 weeks
Number of Subjects With Grade 3/4 Coagulation Abnormalities
Time Frame: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Up to 25 weeks
Number of Subjects With Grade 3/4 Urinalysis Abnormalities
Time Frame: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Up to 25 weeks
Number of Subjects With Grade 3/4 Thyroid Function Abnormalities
Time Frame: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Up to 25 weeks
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time Frame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)
Time Frame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)
Time Frame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)
Time Frame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AVEO Pharmaceuticals, Inc.

Collaborators

Astellas Pharma Inc

Investigators

  • Study Chair: Michael Needle, MD, AVEO Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (ESTIMATE)

August 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV-951-12-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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