A Subject Treatment Preference Study of Tivozanib Hydrochloride Versus Sunitinib in Subjects With Metastatic Renal Cell Carcinoma (TAURUS)
This study is currently recruiting participants.
Verified March 2013 by AVEO Pharmaceuticals, Inc.
Sponsor:
AVEO Pharmaceuticals, Inc.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01673386
First received: August 23, 2012
Last updated: March 12, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Metastatic Renal Cell Carcinoma |
Drug: Tivozanib Hydrochloride Drug: Sunitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by AVEO Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Proportion of subjects who prefer tivozanib hydrochloride or sunitinib [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 160 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673386
Show 38 Study Locations
Contacts
| Contact: Philip Komarnitsky, MD | 617-299-5654 | pkomarnitsky@aveooncology.com |
| Contact: Brooke Esteves, RN | 617-299-5993 | besteves@aveooncology.com |
Show 38 Study LocationsSponsors and Collaborators
AVEO Pharmaceuticals, Inc.
Astellas Pharma Inc
More Information
Additional Information:
No publications provided
| Responsible Party: | AVEO Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01673386 History of Changes |
| Other Study ID Numbers: | AV-951-12-205 |
| Study First Received: | August 23, 2012 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Food and Drug Administration Belgium: Agence Fédérale des Médicaments et des Produits de Santé (AFMPS/FAGG) France: Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Italy: Ministry of Health, Agenzia Italiana del Farmaco (AIFA) Spain: Área de Ensayos Clínicos, Subdirección General de Medicamentos de Uso Humano, Unidad de Registro y Tasas de la AEMPS UK: Medicines & Healthcare products Regulatory Agency |
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 Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013