NCT01204177已完成2 期
A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 70
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.
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 age >/= 18 years of age
- •Life expectancy >/= 12 weeks
- •Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic
- •Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
- •Adequate bone marrow, liver and renal function
排除标准
- •Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
- •History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension
- •Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
- •Renal failure requiring hemo- or peritoneal dialysis
- •Known human immunodeficiency virus (HIV) infection
- •Known history or symptomatic metastatic brain or meningeal tumors
- •History of organ allograft.
- •History of interstitial lung disease (ILD).
- •Excluded previous therapies and medications:
- •Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy
- •Radiotherapy within 4 weeks prior to start of study treatment
- •Any other investigational agents within 4 weeks from the first dose of study treatment
- •Major surgery within 4 weeks of start of study
- •Concomitant use of strong inhibitors and strong inducers of CYP3A4
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY86-9766 MEK Inhibitor + Sorafenib (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: From first dose of combination treatment until last tumor evaluation
次要结局
- Overall Survival (OS)(1st dose of study medication to last date of follow up)
- Time To Progression (TTP)(1st dose of study medication until disease progression)
- Response Rate (RR)(1st dose of study medication until last tumor evaluation)
- Duration Of Response (DOR)(1st dose of study medication until last tumor evaluation)
- Safety: physical examination, vital signs, adverse events, safety lab(At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT)
- Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)(At day 1 of each cycle and within 7 day after the last treatment)
- Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)(Day -3, cycle 2 (day 1))
- Biomarkers(At screening, day 1 of cycle 1 - 4, EOT)
研究者
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