EUCTR2017-001987-39-AT进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study have to meet all of the
- •following criteria:
- •1. Patient 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.
- •2. In the opinion of the Investigator would benefit from continued
- •3. Patient has demonstrated compliance, as assessed by the Investigator, within the parent study protocol requirement(s).
- •4. Willingness and ability to comply with scheduled visits, treatment
- •plans and any other study procedures.
- •5. 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.
- •6. Does not require treatment with prohibited concomitant medications
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Subjects eligible for this study must not meet any of the following criteria:
- •1. Subject has been previously permanently discontinued from study
- •treatment in the parent protocol due to any reason.
- •2. Subject's indication is commercially available and reimbursed in the local country.
- •3. Subject currently has unresolved toxicities for which dabrafenib
- •and/or trametinib dosing has been interrupted in the parent study.
- •4. Pregnant or nursing (lactating) women who are lactating must
- •discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 4 months following the last dose of study treatment.
- •5. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during dosing 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).
- •Highly effective contraception methods include:
- •Total abstinence (when this is in line with the preferred and usual
- •lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation,
- •symptothermal, post-ovulation methods) and withdrawal are not
- •acceptable methods of contraception.
- •Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- •Male sterilization (at least 6 months prior to taking study drug). The
- •vasectomized male partner should be the sole partner for that subject.
- •Dabrafenib monotherapy or in combination with trametinib: Placement of a hormonal or non-hormonal intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year.
- •Trametinib monotherapy only: Use of oral (estrogen and progesterone), injected or implanted combined hormonal methods of contraception or placement of an IUD or IUS, or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- •Double-barrier contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent
- •(foam/gel/cream/suppository) are not considered highly effective
- •methods of contraception.
- •Hormonal-based methods (e.g., oral contraceptives) are not
- •considered as highly effective methods of contraception due to potential drug-drug interactions with dabrafenib
- •Women are considered post-menopausal and not of child bearing
- •potential if they have had 12 months of natural (spontaneous)
- •amenorrhea with an appropriate clinical profile (i.e. age appropriate,
- •history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential.
- •6. Sexually active males (including those that have ha
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