A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 903
- 主要终点
- Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
研究概览
简要总结
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
详细描述
Overall Survival (OS), Patient-reported outcome (PRO)
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
- •Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
- •Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
- •Patients who have adequate coagulation, liver and kidney functions
排除标准
- •Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
- •Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
- •Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
- •Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •Patients with a history or presence of metastatic brain or meningeal tumors
- •Patients with seizure disorder requiring medication (such as anti-epileptics)
- •History of organ allograft or bone marrow transplant of stem cell rescue
- •Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
- •Patients who have three or more of the following:
- •ECOG performance status greater than or equal to 2,
- •Abnormally high lactate dehydrogenase,
- •Abnormally high serum hemoglobin,
- •Abnormally high corrected serum calcium,
- •Absence of prior nephrectomy
- •Excluded therapies and medications, previous and concomitant:
- •Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
- •Significant surgery with 4 weeks of start of study
- •Investigational drug therapy during or within 30 days
- •Concomitant treatment with rifampin or St. John's Wort
- •Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
- •Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006)
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
干预措施: Placebo (Drug)
结局指标
主要结局
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
时间窗: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population
时间窗: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
次要结局
- Best Overall Response - Independent Radiological Review(From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.)
- Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment(From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.)
- Final Progression-Free Survival (PFS) - Independent Radiological Review(From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.)
- Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment(From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.)