NCT01223027已完成3 期
An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 564
- 试验地点
- 35
- 主要终点
- Progression Free Survival (PFS) Per Independent Central Radiology Review
研究概览
简要总结
This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell
- •Patients must have received one and only one prior VEGF-targeted therapy and one and only one prior mTOR inhibitor therapy in the metastatic setting. One VEGF targeted therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and one prior mTOR inhibitor therapy (everolimus, or temsirolimus or ridaforolimus)
- •Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.
- •Patients must have had disease progression on or within 6 months of stopping the last therapy.
- •Patients must have at least one measurable lesion at baseline (by RECIST Criteria Guidelines v1.1) assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
- •Karnofsky performance status ≥ 70%
- •Patients must have the following laboratory values:
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Hemoglobin (Hgb) > 9 g/dL
- •Serum total bilirubin: ≤ 1.5 x ULN
- •ALT and AST ≤ 3.0 x ULN (Patients with known liver metastases: AST and ALT ≤ 5.0 x ULN)
- •Serum creatinine ≤ 1.5 x ULN
排除标准
- •Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant or metastatic setting.
- •Patients who have previously received Dovitinib or brivanib in the neoadjuvant, adjuvant or metastatic setting.
- •Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the brain is required at screening/baseline
- •Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
- •Patients who have received the last administration of an anticancer targeted small molecule therapy ≤ 2 weeks prior to starting study treatment (e.g. sunitinib, pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from the side effects of such therapy
- •Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study treatment, or who have not recovered from the side effects of such therapy
- •Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
- •Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months
- •Patients with concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Dovitinib + best supportive care (BSC)
Experimental
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule.
干预措施: Dovitinib (Drug)
Sorafenib + BSC
Active Comparator
Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Per Independent Central Radiology Review
时间窗: Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)
Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.
次要结局
- Overall Survival (OS)(until at least 386 deaths are documented in the clinical database.)
- Progression Free Survival (PFS) Per Investigator's Radiology Review(Until disease progression or discontinuation of treatment due to unacceptable toxicity)
- Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review(Until disease progression or discontinuation of treatment due to unacceptable toxicity)
- Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores(from date of randomization, at least 2 score units)
- Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%(from date of randomization)
- Time to Definitive Worsening of Karnofsky Performance Status (KPS)(from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier)
- Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%(from date of randomization)
- Pre-dose Concentration in Plasma in Dovitinib(Week 2 Day 5, Week 4 Day 5, Week 6 Day 5)
研究者
研究点 (35)
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