EUCTR2013-002616-28-NL进行中（未招募）不适用
Cytoreductive treatment of dabrafenib combined with trametinib to allow complete surgical resection in patients with BRAF mutated, prior unresectable stage III or IV melanoma - Presurgical MAPK inhibition in stage III-IV melanoma
KI-AV0 个研究点开始时间: 2013年9月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Patients have provided signed informed consent.
- •2.Patients have unresectabel stage III melanoma (documented and based on MSD) or stage IV melanoma with = 3 resectable metastases/organ site.
- •3.Patients have pathologically confirmed BRAF mutation-positive (V600E/K) melanoma as determined via in-house testing with a BRAF mutation assay.
- •4.Patients are treatment naïve for unresectable melanoma.
- •5.Patients for whom the intended operation is considered to offer a chance of cure or substantial palliation.
- •6.Patients have evaluable disease by CT/MRI or PET with = 3 metastases/organ sites.
- •7.Patients are =18 years of age.
- •8.Patients are able to swallow and retain oral medication.
- •9.Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
- •10.Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first dose of study treatment.
- •11.Patients have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- •12.Patients must have adequate organ function as defined in the protocol. Treatment with transfusion, growth factors to meet eligibility criteria will not be allowed.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Patients with known ocular or primary mucosal melanoma.
- •2. Patients who used any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of dabrafenib + trametinib.
- •3. Patients who currently use a prohibited medication or are expected to require any of these medications during treatment with dabrafenib and trametinib.
- •4. Patients who had any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
- •5. Patients with active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
- •6. Patients with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •7. Patients with a history of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
- •8. Patients with a history of alcohol or drug abuse within 6 months prior to screening.
- •9. Patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, or unwillingness or inability to follow the procedures required in the protocol.
- •10.Patients with the cardiac abnormalities as defined in the protocol.
- •11.Pregnant or lactating female.
- •12.Patients with CNS metastases.
研究者
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