ACTRN12613000737730进行中（未招募）2 期
An open label, single centre, phase II pilot study to determine the pathological response rate to 12 weeks of neoadjuvant dabrafenib + trametinib in patients with resectable AJCC Stage IIIB-C BRAF V600 mutation positive melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •>18 years of age
- •Written informed consent
- •Histologically confirmed AJCC Stage IIIB or IIIC cutaneous melanoma or unknown primary and V600 mutation positive with sufficient nodal disease to enable 4 biopsies (core, excisional or incisional).
- •Able to swallow and retain oral medication
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Adequate organ function
- •Women of childbearing potential: negative serum pregnancy test and effective contraception from 14 days prior to study treatment until 4 months after the last dose
- •Men with female partner of childbearing potential to use effective contraception from 14 days prior to study treatment until 4 months after the last dose
排除标准
- •Mucosal or ocular melanoma or any in-transit metastases
- •Distant metastatic disease on screening
- •Prior systemic anti-cancer treatment (except surgery)
- •Any investigational drug within 28 days or 5 half-lives
- •Current or expected use of a prohibited medication
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments
- •Human Immunodeficiency Virus (HIV)
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Another malignancy or concurrent malignancy unless disease-free for 3 years and with a life expectancy of > 5 years
- •Cardiovascular risk including: QTc =480 msec, uncontrolled arrhythmias, acute coronary syndromes, coronary angioplasty or stenting within 6 months, NYHA = Grade 2 heart failure, intra-cardiac defibrillator or permanent pacemaker, abnormal cardiac valve morphology (= Grade 2), treatment refractory hypertension systolic> 140 mm Hg and/or diastolic > 90 mm Hg
- •Evidence/risk of retinal vein occlusion or central serous retinopathy
- •Serious or unstable pre-existing medical conditions or other conditions that could interfere with the subject’s safety, consent, or compliance
- •Pregnant or breastfeeding females
研究者
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