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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 58
- 主要终点
- Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Tivozanib (Drug)
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.
干预措施: Sunitinib (Drug)
结局指标
主要结局
Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
时间窗: Up to 25 weeks
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
次要结局
- Number of Subjects With AEs and SAEs(Up to 25 weeks)
- Number of Subjects With Dose Interruptions(Up to 25 weeks)
- Number of Subjects With Grade 3/4 Chemistry Abnormalities(Up to 25 weeks)
- Number of Subjects With Grade 3/4 Coagulation Abnormalities(Up to 25 weeks)
- Number of Subjects With Grade 3/4 Urinalysis Abnormalities(Up to 25 weeks)
- Number of Subjects With Grade 3/4 Thyroid Function Abnormalities(Up to 25 weeks)
- 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)
- 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)
- Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)(Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment)
- Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)(Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment)
- Number of Subjects With Dose Reductions(Up to 25 weeks)
- Number of Subjects With Grade 3/4 Hematology Abnormalities(Up to 25 weeks)