NL-OMON51275尚未招募4 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) - CDRB436G2401
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •Subjects eligible for inclusion in this study must meet all of the following
- •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, the subject is likely to benefit from
- •continued treatment.
- •8. Does not require treatment with prohibited concomitant medications.
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.
研究者
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