EUCTR2018-001946-32-CZ进行中（未招募）1 期
A Multicenter, Open-label Phase Ib Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients with Unresectable or Metastatic BRAF V600-mutant MelanomaP/071/2018
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •- Male or female 12 to < 18 years of age at the time of consent/assent.
- •- Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma American Joint Committee on Cancer Stage IIIB, IIIC, or IV.
- •- Presence of BRAF V600E or V600K mutation in tumor tissue as determined by a local or central laboratory.
- •- Evidence of at least one evaluable lesion (measurable or non-measurable) as detected by radiological or photographic methods based on RECIST v1.1.
- •- Adequate cardiac function:
- •a. Left ventricular ejection fraction = 50% as determined by ECHO or MUGA scan and above the institutional lower limit of normal;
- •b. Triplicate average baseline QTcF value = 450 ms.
- •- Adequate bone marrow, organ function, and laboratory parameters:
- •a. Absolute neutrophil count = 1.5 × 109/L;
- •b. Hemoglobin = 9 g/dL with or without transfusions;
- •c. Platelets = 75 × 109/L without transfusions;
- •d. Aspartate aminotransferase and/or alanine aminotransferase = 2.5 × upper limit of normal (ULN); in patients with liver metastases = 5 × ULN;
- •e. Total bilirubin = 1.5 × ULN. Patients with documented Gilbert syndrome or hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the Sponsor;
- •f. Creatinine = 1.5 × institutional ULN for age, or calculated creatinine clearance = 70 mL/min/1.73 m2 (following Schwartz formula).
- •- Adequate performance status at Screening:
- •a. Patients < 16 years old: Lansky Performance Scale score = 80
- •b. Patients 16 to 17 years old: Karnofsky Performance Scale score = 80
- •- Female patients of childbearing potential must agree to take appropriate precautions to avoid pregnancy from screening through 8 weeks following end of therapy and must have a negative pregnancy test at Screening and predose at Day 1.
- •- Males must agree to take appropriate precautions to avoid fathering a child from Screening through 90 days following end of therapy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Presence of BRAFwt or indeterminate melanoma in tumor tissue as determined by local and central laboratory.
- •- Known sensitivity or contraindication to any component of study treatment (binimetinib and encorafenib), or their excipients.
- •- Uveal or mucosal melanoma.
- •- Brain metastases that are uncontrolled or symptomatic, require steroids, are potentially life-threatening or have required radiation within 28 days prior to starting study drug.
- •- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
- •- Prior therapy with a BRAF inhibitor and/or a MEK inhibitor
- •- Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following:
- •a. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 6 months prior to screening,
- •b. Symptomatic chronic heart failure, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia.
- •- Concurrent neuromuscular disorder associated with elevated creatine kinase.
- •- Impairment of gastrointestinal function.
- •- Uncontrolled arterial hypertension despite medical treatment.
- •- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- •- Known active hepatitis B and/or active hepatitis C infection.
- •- Patients who have undergone major surgery or radiotherapy = 2 weeks prior to starting study treatment or who have not recovered from side effects of such procedure.
- •- Pregnant or lactating females.
- •- History of Gilbert’s syndrome.
- •- Receipt of non-topical medication known to be a strong inhibitor or strong inducer of cytochrome P450 3A4 within 3 days prior to Screening.
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