A Subject Treatment Preference Study of Tivozanib Hydrochloride Versus Sunitinib in Subjects With Metastatic Renal Cell Carcinoma - Full Text View

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:

Drug Information available for: Sunitinib malate Sunitinib

Genetic and Rare Diseases Information Center resources: Kidney Cancer Renal Cancer

U.S. FDA Resources

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:

Related Info This link exits the ClinicalTrials.gov site

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 Carcinoma, Renal Cell Adenocarcinoma Kidney Diseases Kidney Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Neoplasms Urologic Diseases	Urologic Neoplasms Sunitinib Angiogenesis Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents Growth Inhibitors Growth Substances Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

A Subject Treatment Preference Study of Tivozanib Hydrochloride Versus Sunitinib in Subjects With Metastatic Renal Cell Carcinoma (TAURUS)