A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer (RCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 49
- 主要终点
- Objective Tumor Response
研究概览
简要总结
This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).
详细描述
The final analysis of efficacy will be performed after last patient has been treated for at least 6 months. Additional periodic safety and efficacy data reviews will be performed for any patients continuing to receive study drug afterwards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female patients >/= 18 years of age.
- •Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (renal cell carcinoma histologically) or cytologically documented.
- •Patients must be previously untreated for advanced disease. Prior palliative radiation therapy is allowed if the target lesion(s) are not included within the radiation field and no more than 30% of the bone marrow is irradiated.
- •Patients who have at least one uni-dimensional measurable lesion by computed tomography (CT-scan) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
- •Patients with "Intermediate" or "Low" risk per the Motzer score.
- •Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or
- •Adequate bone marrow, renal and hepatic function as assessed by the following laboratory requirements to be conducted within 7 days prior to study drug treatment
排除标准
- •Patients who have received prior systemic treatment regimens for RCC.
- •Uncontrolled/unstable cardiac disease
- •Uncontrolled hypertension
- •Active clinically serious infections (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2 )
- •History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
- •Known history or symptomatic metastatic brain or meningeal tumours
- •Patients with seizure disorder requiring medication
- •Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks of first dose of study.
- •Pregnant or breast-feeding patients
研究组 & 干预措施
Regorafenib (Stivarga, BAY73-4506)
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Objective Tumor Response
时间窗: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\] or Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.
Tumor Response
时间窗: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\], Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\], Stable Disease \[SD, steady state of disease\], or Progressive Disease \[PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions\]) observed during trial period assessed according to the RECIST committee.
次要结局
- Overall Survival(From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).)
- Time to Progression (TTP)(From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks)
- Disease Control(From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks)
- Progression-free Survival (PFS)(From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks)
- Duration of Response(From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks)
- Duration of Stable Disease (SD)(From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks)