Clinical trial NCT01673386: A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Tivozanib hydrochloride
renal cell carcinoma
subject preference
quality of life
Lead sponsor: AVEO Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2012-08-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
timeFrame: Up to 25 weeks
Secondary outcomes:
measure: Number of Subjects With AEs and SAEs
timeFrame: Up to 25 weeks
measure: Number of Subjects With Dose Reductions
timeFrame: Up to 25 weeks
measure: Number of Subjects With Dose Interruptions
timeFrame: Up to 25 weeks
measure: Number of Subjects With Grade 3/4 Hematology Abnormalities
timeFrame: Up to 25 weeks
measure: Number of Subjects With Grade 3/4 Chemistry Abnormalities
timeFrame: Up to 25 weeks
measure: Number of Subjects With Grade 3/4 Coagulation Abnormalities
timeFrame: Up to 25 weeks
measure: Number of Subjects With Grade 3/4 Urinalysis Abnormalities
timeFrame: Up to 25 weeks
measure: Number of Subjects With Grade 3/4 Thyroid Function Abnormalities
timeFrame: Up to 25 weeks
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
timeFrame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
measure: Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)
timeFrame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)
timeFrame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
measure: Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)
timeFrame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Albany
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Worcester
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
city: Antwerp
country: Belgium
city: Brussels
country: Belgium
city: Bordeaux
country: France
city: Caen
country: France
city: Lyon
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Munich
country: Germany
city: Aviano
country: Italy
city: Pavia
country: Italy
city: Rome
country: Italy
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Valencia
country: Spain
city: Glasgow
country: United Kingdom
state: Scotland
city: Swansea
country: United Kingdom
state: Wales
city: Cambridge
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: AVEO Pharmaceuticals, Inc.
name: Michael Needle, MD
role: STUDY_CHAIR
References: