A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
- Conditions
- Metastatic Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT01673386
- Lead Sponsor
- AVEO Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tivozanib Hydrochloride Tivozanib 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. Sunitinib 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.
- Primary Outcome Measures
Name Time Method Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib Up to 25 weeks The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
- Secondary Outcome Measures
Name Time Method Number of Subjects With AEs and SAEs Up to 25 weeks Number of subjects with serious and non-serious adverse events.
Number of Subjects With Dose Interruptions Up to 25 weeks The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Chemistry Abnormalities Up to 25 weeks The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Coagulation Abnormalities Up to 25 weeks The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Urinalysis Abnormalities Up to 25 weeks The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Thyroid Function Abnormalities Up to 25 weeks The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D) Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Dose Reductions Up to 25 weeks The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Number of Subjects With Grade 3/4 Hematology Abnormalities Up to 25 weeks The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.