A SINGLE ARM, OPEN LABEL, EXPANDED ACCESS STUDY OF RG7204 IN PREVIOUSLY TREATED PATIENTS WITH METASTATIC MELANOMA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 374
- 主要终点
- Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation
研究概览
简要总结
This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test
- •Patients with either measurable or non-measurable disease
- •Adequate recovery from most recent systemic or local treatment for metastatic melanoma
- •Adequate organ function
- •For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of RO5185426
- •For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of RO5185426
- •Negative serum or urine pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study
- •Agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of RO5185426; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of RO5185426
排除标准
- •Pregnant or breast-feeding
- •Concurrent anti-tumor therapy
- •Uncontrolled medical illness
- •History of congenital prolonged QT syndrome or patients with a mean QTc interval greater than 470 milliseconds at baseline, or ongoing grade 2 or greater cardiac arrhythmia
研究组 & 干预措施
Overall Trial
Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
干预措施: RO5185426 (Drug)
结局指标
主要结局
Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation
时间窗: Up to 1 year
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded according to the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI CTCAE, v4.0). However Laboratory data will be summarized by grade using the NCI CTCAE, v4.0 toxicity grade.
Number of Participants With Any Serious Adverse Event, Death and Cause of Death
时间窗: Up to 1 year
Serious Adverse Event (SAEs) is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Number of participants who died and the cause of death are also recorded.
次要结局
- Number of Participants With Best Overall Response (Unconfirmed)(Up to 1 year)
- Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance(Up to 1 year)
- Number of Participants With Best Overall Response (Confirmed) by ECOG Performance(Up to 1 year)
- Mean Time to Complete Response/Partial Response(Up to 1 year)
- Number of Participants With Best Overall Response (Confirmed)(Up to 1 year)