Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 45
- 主要终点
- Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
研究概览
简要总结
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
- •In the opinion of the Investigator would benefit from continued treatment.
排除标准
- •Patient has been previously permanently discontinued from study treatment in the parent protocol.
- •Patient's indication is commercially available and reimbursed in the local country.
- •Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
研究组 & 干预措施
dabrafenib monotherapy
Patients in this study may receive:
- monotherapy of dabrafenib
干预措施: dabrafenib (Drug)
trametinib monotherapy
Patients in this study may receive:
- monotherapy of trametinib
干预措施: trametinib (Drug)
Combination therapy (dabrafenib & trametinib)
Patients in this study may receive:
- the combination of dabrafenib and trametinib
干预措施: dabrafenib (Drug)
Combination therapy (dabrafenib & trametinib)
Patients in this study may receive:
- the combination of dabrafenib and trametinib
干预措施: trametinib (Drug)
结局指标
主要结局
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
时间窗: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.
次要结局
- Clinical Benefit Assessment by investigator(Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.)