An Open-label, Pilot Study of RO5185426 in Previously Treated Metastatic Melanoma Patients With Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.
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
- •Adult patients, >/= 18 years of age
- •Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)
- •Brain metastases for which surgical resection is not a treatment option
- •Patients must have failed at least one previous treatment for brain metastases
- •Requiring corticosteroids for symptom control
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
排除标准
- •Increasing corticosteroid dose during the 7 days prior to study entry
- •Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
- •Concurrent administration of any anticancer therapies other than those administered in the study
- •Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
研究组 & 干预措施
Single Arm
干预措施: RO5185426 (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: From baseline up to last dose (0.1 to 11.3 months) plus 28 days
AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE.
次要结局
- Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site(Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months))
- Duration of Response by Disease Site(Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months))
- Time to Response by Disease Site(Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months))
- Duration of Stable Disease (SD) by Disease Site(Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months))
- Percentage of Participants With Disease Progression or Death by Disease Site(Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months))
- Percentage of Participants Who Died(Baseline up to end of the study and every 3 months during follow-up (up to 16 months))
- Time to New Lesion by Disease Site(Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months))
- Progression Free Survival (PFS)(Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months))
- Overall Survival (OS)(From start of treatment up to end of the study and every 3 months during follow up (up to 16 months))
- Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids(Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days)
- Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic(Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days)
- Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain(Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months))
- Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status(Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months))