A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC (TAURUS)
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| ClinicalTrials.gov Identifier: NCT01673386 |
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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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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Renal Cell Carcinoma | Drug: Tivozanib Drug: Sunitinib | Phase 2 |
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 (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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Tivozanib
Other Name: Tivozanib Hydrochloride |
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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.
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Drug: Sunitinib
Other Name: Sutent |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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
Locations
| United States, California | |
| Los Angeles, California, United States, 90001 | |
| United States, Georgia | |
| Albany, Georgia, United States, 31701 | |
| Atlanta, Georgia, United States, 30301 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60007 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46077 | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Massachusetts | |
| Worcester, Massachusetts, United States, 01601 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55111 | |
| United States, New York | |
| New York, New York, United States, 10001 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43004 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97035 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29401 | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Texas | |
| San Antonio, Texas, United States, 78006 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53558 | |
| Belgium | |
| Antwerp, Belgium | |
| Brussels, Belgium | |
| France | |
| Bordeaux, France | |
| Caen, France | |
| Lyon, France | |
| Paris, France | |
| Germany | |
| Berlin, Germany | |
| Hamburg, Germany | |
| Hannover, Germany | |
| Heidelberg, Germany | |
| Munich, Germany | |
| Italy | |
| Aviano, Italy | |
| Pavia, Italy | |
| Rome, Italy | |
| Spain | |
| Barcelona, Spain | |
| Madrid, Spain | |
| Pamplona, Spain | |
| Valencia, Spain | |
| United Kingdom | |
| Glasgow, Scotland, United Kingdom | |
| Swansea, Wales, United Kingdom | |
| Cambridge, United Kingdom | |
| London, United Kingdom | |
| Manchester, United Kingdom | |
Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.
Astellas Pharma Inc
Investigators
| Study Chair: | Michael Needle, MD | AVEO Pharmaceuticals, Inc. |
Additional Information:
| Responsible Party: | AVEO Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01673386 |
| Other Study ID Numbers: |
AV-951-12-205 |
| First Posted: | August 28, 2012 Key Record Dates |
| Results First Posted: | October 27, 2020 |
| Last Update Posted: | October 27, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by AVEO Pharmaceuticals, Inc.:
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Tivozanib hydrochloride renal cell carcinoma subject preference quality of life |
Additional relevant MeSH terms:
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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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |