KCT0003700招募中未知
Safety and efficacy of Selumetinib in Korean patients with neurofibromatosis type 1 and plexiform neurofibromas
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 3(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •For inclusion in the study subjects should fulfil the following criteria based on local regulations:
- •1. Patients with Neurofibromatosis type I, in whom genetic study was performed for the germline NF1 mutations, and have significant symptoms/comorbidities as well as those with the potential to develop symptoms/comorbidities due to inoperable measurable plexiform neurofibroma (Surgeon’s statement of inoperability should be documented).
- •2. Patients must have at least one measurable plexiform neurofibroma, defined as a lesion of at least 3 cm measured in one dimension.
- •3. Patients with an absolute neutrophil count =1000/µL, hemoglobin = 9 g/dL, and platelet = 100,000/µL.
- •4. Patients must have bilirubin within 1.5 x the upper limit of normal for age, with the exception of Gilbert syndrome, and Alanie aminotranferaase and aspartate aminotranferase within = 1.5 x upper limit of normal.
- •5. Renal Function: age-adjusted normal serum creatinine.
- •6. Cardiac function: Normal ejection fraction; echocardiogram = 55% (if a range is given then the upper value of the range will be used).
- •7. Performance status: Patients = 16 years of age must have a Karnofsky performance level of =70%, and children < 16 years old must have a Lansky performance of =70%
- •8. Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is <19 years old). When appropriate, pediatric patients will be included in all discussions.
排除标准
- •1.Any prior exposure to MEK, RASs, or RAF inhibitors, or any treatment regimen that involves the comparator / combination medications.
- •2.Known severe hypersensitivity to selumetinib, comparator or combination medications or any excipient of these medicinal products or history of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or comparator
- •3.Have received or are receiving an investigational medicinal product (IMP) or other systemic anticancer treatment within 4 weeks.
- •4.Have had recent major surgery within a minimum 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access.
- •5.The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment.
- •6.Evidence of a malignant glioma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy.
- •7.Any unresolved toxicity = CTCAE (Common Terminology Criteria for Adverse Events) Grade 2 from previous anti-cancer therapy, except for alopecia
- •8.Cardiac conditions as follows:
- •a.Uncontrolled hypertension (BP = 150/95 mmHg despite medical therapy)
- •b.Acute coronary syndrome within 6 months prior to starting treatment
- •c.Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical therapy
- •d.Symptomatic heart failure NYHA Class II-IV, prior or current cardiomyopathy, or severe valvular heart disease
- •e.Prior or current cardiomyopathy including but not limited to the following:
- •i.Known hypertrophic cardiomyopathy
- •ii.Known arrhythmogenic right ventricular cardiomyopathy
- •f.Previous moderate or severe impairment of left ventricular systolic function (Left ventricular ejection fraction <45% on echocardiography or equivalent on multiple gated acquisition scan) even if full recovery has occurred.
- •g.Severe valvular heart disease
- •h.Baseline Left ventricular ejection fraction below the lower limit of normal or <55% measured by echocardiography or institution’s lower limit of normal for multiple gated acquisition scan
- •i.Atrial fibrillation with a ventricular rate >100 bpm on electrocardiogram at rest
- •j.QTcF >450ms or other factors that increase the risk of QT prolongation
- •9.Laboratory values as listed below (SI units):
- •a.Absolute Neutrophil Count <1.5x1000,000,000/L (1500 per mm3)
- •b.Platelets <100x1000,000,000/L (100,000 per mm3)
- •c.Hemoglobin =9.0 g/dL
- •d.Serum creatinine =1.5 X upper limit of normal (ULN)
- •e.Serum bilirubin >1.5 x ULN (Note that this will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology), who may be allowed included in specific studies, at the discretion of the doctor / physician responsible for the treatment.)
- •f.Alanine aminotransferase or Aspartate aminotransferase > 2.5 x Upper limit of normal for patients with no liver metastasis.
- •g.Alanine aminotransferase or Aspartate aminotransferase > 5 x Upper limit of normal for patients with liver metastasis.
- •h.Alanine aminotransferase or Aspartate aminotransferase > 3.5 x Upper limit of normal and < 5 x Upper limit of normal for patients with liver metastasis and Alakaline phosphatase > 6 x Upper limit of normal
- •10.Ophthalmological conditions a
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