NL-OMON51217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 - CDRB436X2X02B
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 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
- 18 至 64（—）
入选标准
- •Patients eligible for inclusion in this study have to meet all of the following
- •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 treatment.
- •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
- •6. Does not require treatment with prohibited concomitant medications
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
- •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). For more information, please refer to the protocol.
- •6. Sexually active males (including those that have had a vasectomy) taking the
- •dabrafenib and/or trametinib therapy must use a condom during intercourse, and
- •should not father a child during this period. The minimum amount of time a
- •subject must use a condom after last treatment is as follows:
- •16 weeks post treatment discontinuation dabrafenib in combination with
- •2 weeks after treatment with dabrafenib monotherapy
- •16 weeks after treatment with trametinib monotherapy
研究者
相似试验
进行中（未招募）
1 期
This clinical study is designed to provide continued access to pediatric patients who have previously participated in a dabrafenib and/or trametinib study and who in the opinion of the Investigator, would benefit from continued treatmentChildren and Adolescents with Cancers Harboring V600 mutationsEUCTR2018-004459-19-DEovartis Pharma AG250
进行中（未招募）
1 期
This clinical study is designed to provide continued access to pediatric patients who have previously participated in a dabrafenib and/or trametinib study and who in the opinion of the Investigator, would benefit from continued treatmentChildren and Adolescents with Cancers Harboring V600 mutationsEUCTR2018-004459-19-FIovartis Pharma AG250
进行中（未招募）
1 期
This clinical study is designed to provide continued access to patients who have previously participated in a dabrafenib and/or trametinib study and who in the opinion of the Investigator, would benefit from continued treatmentPatients with BRAF V600 mutation positiveMedDRA version: 27.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001987-39-ATovartis Pharma AG78
进行中（未招募）
1 期
This clinical study is designed to provide continued access to patients who have previously participated in a dabrafenib and/or trametinib study and who in the opinion of the Investigator, would benefit from continued treatmentPatients with BRAF V600 mutation positiveMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864EUCTR2017-001987-39-FRovartis Pharma AG100
进行中（未招募）
3 期
Study to allow access to dabrafenib and/or trametinib for subjects that are benefiting from dabrafenib and/or trametinib treatment in a Novartis or GSK sponsored studyRare CancersJPRN-jRCT2031210131Suzuki Kazuyuki2