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

• ClinicalTrials.gov Identifier: NCT01673386
• Recruitment Status: Terminated
• First Posted: August 28, 2012
• Results First Posted: October 27, 2020
• Last Update Posted: October 27, 2020
• Sponsor: AVEO Pharmaceuticals, Inc.
• Collaborator: Astellas Pharma Inc
• Information provided by (Responsible Party): AVEO Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: August 23, 2012
• First Posted Date: August 28, 2012
• Results First Submitted Date: July 7, 2020
• Results First Posted Date: October 27, 2020
• Last Update Posted Date: October 27, 2020
• Study Start Date: July 2012
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: August 27, 2012): Proportion of subjects who prefer tivozanib hydrochloride or sunitinib [ Time Frame: Up to 25 weeks ]

Current Secondary Outcome Measures (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 (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: A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Metastatic Renal Cell Carcinoma

Intervention

• Drug: Tivozanib
  Other Name: Tivozanib Hydrochloride
• Drug: Sunitinib
  Other Name: Sutent

Study Arms

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 22, 2015): 58
• Original Estimated Enrollment (submitted: August 27, 2012): 160
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Germany, Italy, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT01673386
• Other Study ID Numbers: AV-951-12-205
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AVEO Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: AVEO Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Astellas Pharma Inc

Investigators

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

• PRS Account: AVEO Pharmaceuticals, Inc.
• Verification Date: October 2020