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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01673386
First received: August 23, 2012
Last updated: January 23, 2014
Last verified: January 2014

August 23, 2012
January 23, 2014
July 2012
January 2014   (final data collection date for primary outcome measure)
Proportion of subjects who prefer tivozanib hydrochloride or sunitinib [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01673386 on ClinicalTrials.gov Archive Site
  • Number of subjects with AEs and SAEs [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with dose reductions [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with dose interruptions [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Grade 3/4 hematology abnormalities [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Grade 3/4 chemistry abnormalities [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Grade 3/4 coagulation abnormalities [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Grade 3/4 urinalysis abnormalities [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Grade 3/4 thyroid function abnormalities [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Subject Treatment Preference Study of Tivozanib Hydrochloride Versus Sunitinib in Subjects With Metastatic Renal Cell Carcinoma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Metastatic Renal Cell Carcinoma
  • Drug: Tivozanib Hydrochloride
  • Drug: Sunitinib
  • 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 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.
    Intervention: Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01673386
AV-951-12-205
No
AVEO Pharmaceuticals, Inc.
AVEO Pharmaceuticals, Inc.
Astellas Pharma Inc
Not Provided
AVEO Pharmaceuticals, Inc.
January 2014

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