2023-509318-13-00招募中4 期
An open label, multi-center roll-over study to assess long-term safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 15
- 主要终点
- Frequency and severity of AEs/SAEs.
研究概览
简要总结
The primary objective is to evaluate long-term safety as assessed by occurrence of AEs/SAEs.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Subject is currently receiving treatment with dabrafenib and/or 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.
- •Subject has demonstrated compliance, as assessed by the Investigator, within the parent study protocol requirement(s).
- •Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
- •Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
- •Does not require treatment with prohibited concomitant medications.
排除标准
- •Subject has been previously permanently discontinued from study treatment in the parent protocol.
- •Subject’s indication is commercially available and reimbursed in the local country.
- •Subject currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
- •Female subjects who are lactating, unless they are willing discontinue nursing prior to first dose of study treatment, and willing to refrain from nursing throughout the treatment period and for 4 months following the last dose of study treatment.
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception whilst taking study treatment and for 16 weeks after stopping treatment with trametinib (for trametinib monotherapy trials); 2 weeks after stopping treatment with dabrafenib (for dabrafenib monotherapy trials); 16 weeks after stopping treatment with trametinib or 2 weeks after stopping treatment with dabrafenib, whichever is longer (for trials of dabrafenib in combination with trametinib).
- •Sexually active males unwilling to use a condom during intercourse whilst taking study treatment and for: 16 weeks after stopping study treatment with dabrafenib in combination with trametinib 2 weeks after stopping study treatment with dabrafenib monotherapy 16 weeks after stopping study treatment with trametinib monotherapy A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above.
结局指标
主要结局
Frequency and severity of AEs/SAEs.
Frequency and severity of AEs/SAEs.
次要结局
- Proportion of subjects with clinical benefit as assessed by the Investigator at scheduled visits.
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (15)
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