A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC (TAURUS)
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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
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Sponsor:
AVEO Pharmaceuticals, Inc.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Metastatic Renal Cell Carcinoma |
Interventions |
Drug: Tivozanib Drug: Sunitinib |
Enrollment | 58 |
Participant Flow
Recruitment Details | All screening assessments were performed within 28 days prior to the first dose of study drug. All subjects were recruited as per the inclusion and exclusion criteria. |
Pre-assignment Details |
Arm/Group Title | Tivozanib First, Then Sunitinib | Sunitinib First, Then Tivosanib |
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Subject randomized to this arm received 1.5 mg oral tivozanib hydrochloride (drug 1) daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib (drug 2) daily on a 4 weeks on/2 weeks off schedule for 12 weeks. | Subject randomized to this arm received 50 mg oral sunitinib (drug 1) daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride (drug 2) daily on a 3 weeks on/1 week off schedule for 12 weeks. |
Period Title: Overall Study | ||
Started | 27 | 31 |
Completed | 2 [1] | 4 [2] |
Not Completed | 25 | 27 |
Reason Not Completed | ||
Study terminated by sponsor | 16 | 22 |
Adverse Event | 5 | 2 |
Progressive disease | 4 | 1 |
Withdrawal by Subject | 0 | 2 |
[1]
Of 2 subjects, 1 subject discontinued tivozanib early, completed planned treatment with sunitinib.
[2]
Of 4 subjects, 3 subjects discontinued sunitinib early, completed planned treatment with tivozanib.
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Baseline Characteristics
Arm/Group Title | Overall Study | |
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Subjects randomized to Arm 1, received 1.5 mg oral tivozanib daily on a 3 week on/1 week off schedule for 12 weeks (3 cycles) followed by 50 mg oral sunitinib daily on a 4 week on/2 week off schedule for 12 weeks (2 cycles). Subjects randomized to Arm 2, received 50 mg oral sunitinib daily on a 4 week on/2 weeks off schedule for 12 weeks followed by 1.5 mg oral tivozanib daily on a 3 week on/1 week off schedule. | |
Overall Number of Baseline Participants | 58 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
26 44.8%
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>=65 years |
32 55.2%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 58 participants | |
65.5
(38 to 80)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | |
Female |
10 17.2%
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Male |
48 82.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
1 1.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
1 1.7%
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White |
56 96.6%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
The Sponsor terminated Study AV-951-12-205 before enrollment was completed, following the negative decision of the US FDA.
More Information
Results Point of Contact
Name/Title: | Chief Medical Officer |
Organization: | AVEO Pharmaceuticals, Inc. |
Phone: | 857-400-0101 |
EMail: | Clinical@aveooncology.com |
Responsible Party: | AVEO Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01673386 |
Other Study ID Numbers: |
AV-951-12-205 |
First Submitted: | August 23, 2012 |
First Posted: | August 28, 2012 |
Results First Submitted: | July 7, 2020 |
Results First Posted: | October 27, 2020 |
Last Update Posted: | October 27, 2020 |