A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC

Phase 2TerminatedNCT01673386

AVEO Pharmaceuticals, Inc.58 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Metastatic Renal Cell Carcinoma

Interventions

TivozanibDRUG

SunitinibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (38)

Unnamed facility

Los Angeles, California, United States

Outcomes

Primary Outcomes

Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Time frame: Up to 25 weeks

Secondary Outcomes

Number of Subjects With AEs and SAEs

Number of subjects with serious and non-serious adverse events.

Time frame: Up to 25 weeks

Number of Subjects With Dose Reductions

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Time frame: Up to 25 weeks

Number of Subjects With Dose Interruptions

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Time frame: Up to 25 weeks

Number of Subjects With Grade 3/4 Hematology Abnormalities

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Time frame: Up to 25 weeks

Number of Subjects With Grade 3/4 Chemistry Abnormalities

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Time frame: Up to 25 weeks

Number of Subjects With Grade 3/4 Coagulation Abnormalities

The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.

Data from ClinicalTrials.gov

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