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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01673386
Recruitment Status : Terminated (Sponsor)
First Posted : August 28, 2012
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Tivozanib Drug: Sunitinib Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Sutent


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of Subjects With AEs and SAEs [ Time Frame: Up to 25 weeks ]
    Number of subjects with serious and non-serious adverse events.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673386


Locations
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United States, California
Los Angeles, California, United States, 90001
United States, Georgia
Albany, Georgia, United States, 31701
Atlanta, Georgia, United States, 30301
United States, Illinois
Chicago, Illinois, United States, 60007
United States, Indiana
Indianapolis, Indiana, United States, 46077
United States, Louisiana
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Worcester, Massachusetts, United States, 01601
United States, Minnesota
Minneapolis, Minnesota, United States, 55111
United States, New York
New York, New York, United States, 10001
United States, Ohio
Columbus, Ohio, United States, 43004
United States, Oregon
Portland, Oregon, United States, 97035
United States, South Carolina
Charleston, South Carolina, United States, 29401
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
San Antonio, Texas, United States, 78006
United States, Wisconsin
Madison, Wisconsin, United States, 53558
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
Glasgow, Scotland, United Kingdom
Swansea, Wales, United Kingdom
Cambridge, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.
Astellas Pharma Inc
Investigators
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Study Chair: Michael Needle, MD AVEO Pharmaceuticals, Inc.
More Information
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Additional Information:

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Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01673386    
Other Study ID Numbers: AV-951-12-205
First Posted: August 28, 2012    Key Record Dates
Results First Posted: October 27, 2020
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AVEO Pharmaceuticals, Inc.:
Tivozanib hydrochloride
renal cell carcinoma
subject preference
quality of life
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action