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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.

Tracking Information
First Submitted Date  ICMJE August 23, 2012
First Posted Date  ICMJE August 28, 2012
Results First Submitted Date  ICMJE July 7, 2020
Results First Posted Date  ICMJE October 27, 2020
Last Update Posted Date October 27, 2020
Study Start Date  ICMJE July 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib [ Time Frame: Up to 25 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Number of Subjects With AEs and SAEs [ Time Frame: Up to 25 weeks ]
    Number of subjects with serious and non-serious adverse events.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
  • Number of Subjects With AEs and SAEs [ Time Frame: Up to 25 weeks ]
  • Number of Subjects With Dose Reductions [ Time Frame: Up to 25 weeks ]
  • Number of Subjects With Dose Interruptions [ Time Frame: Up to 25 weeks ]
  • Number of Subjects With Grade 3/4 Hematology Abnormalities [ Time Frame: Up to 25 weeks ]
  • Number of Subjects With Grade 3/4 Chemistry Abnormalities [ Time Frame: Up to 25 weeks ]
  • Number of Subjects With Grade 3/4 Coagulation Abnormalities [ Time Frame: Up to 25 weeks ]
  • Number of Subjects With Grade 3/4 Urinalysis Abnormalities [ Time Frame: Up to 25 weeks ]
  • Number of Subjects With Grade 3/4 Thyroid Function Abnormalities [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Tivozanib
    Other Name: Tivozanib Hydrochloride
  • Drug: Sunitinib
    Other Name: Sutent
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Tivozanib
  • 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.
    Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 22, 2015)
58
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2012)
160
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01673386
Other Study ID Numbers  ICMJE AV-951-12-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AVEO Pharmaceuticals, Inc.
Study Sponsor  ICMJE AVEO Pharmaceuticals, Inc.
Collaborators  ICMJE Astellas Pharma Inc
Investigators  ICMJE
Study Chair: Michael Needle, MD AVEO Pharmaceuticals, Inc.
PRS Account AVEO Pharmaceuticals, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP