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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
  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
Study Completion Date: January 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673386

  Show 38 Study Locations
Sponsors 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: January 23, 2014
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, Renal Cell
Kidney Neoplasms
Kidney Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
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 September 30, 2014