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A Subject Treatment Preference Study of Tivozanib Hydrochloride Versus Sunitinib in Subjects With Metastatic Renal Cell Carcinoma (TAURUS)

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ClinicalTrials.gov Identifier: NCT01673386
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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.

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

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

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U.S. FDA Resources

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 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


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 ]

Secondary Outcome Measures :
  1. Number of subjects with AEs and SAEs [ Time Frame: Up to 25 weeks ]
  2. Number of subjects with dose reductions [ Time Frame: Up to 25 weeks ]
  3. Number of subjects with dose interruptions [ Time Frame: Up to 25 weeks ]
  4. Number of subjects with Grade 3/4 hematology abnormalities [ Time Frame: Up to 25 weeks ]
  5. Number of subjects with Grade 3/4 chemistry abnormalities [ Time Frame: Up to 25 weeks ]
  6. Number of subjects with Grade 3/4 coagulation abnormalities [ Time Frame: Up to 25 weeks ]
  7. Number of subjects with Grade 3/4 urinalysis abnormalities [ Time Frame: Up to 25 weeks ]
  8. Number of subjects with Grade 3/4 thyroid function abnormalities [ Time Frame: Up to 25 weeks ]
  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 ]
  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 ]
  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 ]
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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


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Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.
Astellas Pharma Inc
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01673386     History of Changes
Other Study ID Numbers: AV-951-12-205
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by AVEO Pharmaceuticals, Inc.:
Tivozanib hydrochloride
renal cell carcinoma
subject preference
quality of life

Additional relevant MeSH terms:
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