EUCTR2018-004459-19-NL进行中（未招募）1 期
An open label, multi-center roll-over study to assess long-term effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •Subjects eligible for inclusion in this study must meet all of the following criteria:
- •All subjects
- •1. Written informed consent, according to local guidelines, signed by the patients and / or by the parents or legal guardian prior to any study related screening procedures are performed.
- •2. Participation in a Novartis sponsored study such as TMT212X2101, DRB436G2201, DRB436A2102, regardless of current age
- •3. Parent study (or cohort of parent study) is planned to be closed
- •4. Patient has demonstrated treatment compliance, as assessed by the Investigator, within the parent study protocol requirement(s).
- •5. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
- •For Subjects Entering the Treatment Period
- •6. Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis Sponsored Drug Development study.
- •7. In the opinion of the Investigator is likely to benefit from continued treatment.
- •8. Does not require treatment with prohibited concomitant medications.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 250
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication. (Exception: Patients who were on the chemotherapy arm of the CDRB436G2201 study are eligible for this study after crossing over into the experimental treatment arm of the CDRB436G2201 study or have discontinued the study treatment and are now in follow-up)
- •2. Patient has permanently discontinued from study treatment in the parent protocol due to any reason.
- •3. Treatment with dabrafenib and/or trametinib for the patient’s indication is approved for marketing and the appropriate dosage form is commercially available and reimbursed in the local country
- •4. Patient currently has unresolved drug related severe toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study. If the patient should meet criteria to resume treatment on the parent protocol then they may be eligible for enrolment in this study.
- •5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, not willing to 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:
- •a. 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.
- •b. 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.
- •c. Sterilization (at least 6 months prior to screening) for male partners. The vasectomized male partner should be the sole partner for that subject.
- •d. 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.
- •Male patients (including those that have had a vascetomy) not willing to use a condom during intercourse while taking trametinib and/or dabrafenib and not to father a child during the study and for the period of 16 weeks following stopping of study treatment.
- •If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).
- •8. Lactating females who are actively breast feeding.
- •9. Concurrent participation in other clinical trials using experimental therapies
研究者
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