Metastatic Renal Cell CarcinomaPhase 2TAURUSNCT01673386
A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
A Phase 2 study testing Tivozanib and Sunitinib in people with Metastatic Renal Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 38 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Tivozanib and Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 38 sitesin 7 countries
- Study dates
- Jul 2012to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
United States15 sites
Study site
Albany, Georgia, 31701
Study site
Atlanta, Georgia, 30301
Study site
Charleston, South Carolina, 29401
Study site
Chicago, Illinois, 60007
Study site
Columbus, Ohio, 43004
Study site
Indianapolis, Indiana, 46077
Study site
Los Angeles, California, 90001
Study site
Madison, Wisconsin, 53558
Study site
Minneapolis, Minnesota, 55111
Study site
Myrtle Beach, South Carolina, 29572
Study site
New York, New York, 10001
Study site
Portland, Oregon, 97035
Study site
San Antonio, Texas, 78006
Study site
Shreveport, Louisiana, 71101
Study site
Worcester, Massachusetts, 01601
Germany5 sites
Study site
Berlin
Study site
Hamburg
Study site
Hanover
Study site
Heidelberg
Study site
Munich
United Kingdom5 sites
Study site
Cambridge
Study site
Glasgow, Scotland
Study site
London
Study site
Manchester
Study site
Swansea, Wales
France4 sites
Study site
Bordeaux
Study site
Caen
Study site
Lyon
Study site
Paris
Spain4 sites
Study site
Barcelona
Study site
Madrid
Study site
Pamplona
Study site
Valencia
About this study
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
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).
Read the 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Tivozanib, Sunitinib
- Keywords
- Tivozanib hydrochloride, renal cell carcinoma, subject preference, quality of life
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TivozanibDrug
Also called Tivozanib Hydrochloride
SunitinibDrug
Also called Sutent
| Study group | Role | What they receive |
|---|---|---|
| Tivozanib Hydrochloride | Experimental | 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. Receives: Drug: Tivozanib |
| Sunitinib | Active comparator | 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. Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Up to 25 weeks
Secondary outcomes (12)
Number of Subjects With AEs and SAEs
Number of subjects with serious and non-serious adverse events.
Measured: Up to 25 weeks
Number of Subjects With Dose Reductions
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Up to 25 weeks
Number of Subjects With Dose Interruptions
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Up to 25 weeks
Number of Subjects With Grade 3/4 Hematology Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Up to 25 weeks
Number of Subjects With Grade 3/4 Chemistry Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Up to 25 weeks
Number of Subjects With Grade 3/4 Coagulation Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Up to 25 weeks
Number of Subjects With Grade 3/4 Urinalysis Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Up to 25 weeks
Number of Subjects With Grade 3/4 Thyroid Function Abnormalities
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Up to 25 weeks
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: 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)
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Measured: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Michael Needle, MD, Study chair, AVEO Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673386
- Sponsor's protocol ID
- AV-951-12-205
- Acronym
- TAURUS
- Status last verified
- Oct 2020
- First submitted
- 23 Aug 2012
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01673386
- Acronym / sponsor ID
- TAURUS / AV-951-12-205
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Tivozanib hydrochloride, renal cell carcinoma, subject preference, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 27 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tivozanib Hydrochloride | Experimental | Drug: Tivozanib1.5 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. |
| Sunitinib | Active comparator | Drug: Sunitinib50 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TivozanibAlso: Tivozanib Hydrochloride | Drug | Tivozanib Hydrochloride |
| SunitinibAlso: Sutent | Drug | Sunitinib |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Aveo Pharmaceuticals, Inc. official web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Needle, MD study chair
AVEO Pharmaceuticals, Inc.
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tivozanib and Sunitinib in people with Metastatic Renal Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 38 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Germany, United Kingdom, France, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib (time frame: Up to 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.