EUCTR2014-005428-81-FR进行中（未招募）1 期
A Phase I/II, Open-Label, Multicentre Study to Assess The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of AZD4547 in Patients with glioma positive for an FGFR fusion Relapsed/Refractory -TARGET study - TARGET
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
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
入选标准
- •Recurrent grade III or IV glioma with FGFR3-TACC3 or FGFR1-TACC1 fusion positive by RT-PCR
- •Recurrence occurring more than three months from the end of the radiotherapy or occurring outside the irradiated volume
- •Age 18 years
- •WHO 0-2 (KPS>50)
- •Adequate biological parameters: blood count, renal function, liver function, calcium, phosphate
- •Use of effective means of contraception (men and women) in subjects of child-bearing potential or evidence of post-menopausal status
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Pregnancy or breast-feeding women
- •Congestive heart failure, long QT or risk factors for long QT, important abnormalities in rhythm and heart conduction
- •History of myocardial infarction, unstable angina, stroke or transient ischemic attack within the last 6 months
- •Major surgical procedure (excluding placement of vascular access) within 2 weeks prior to study enrolment
- •As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
- •Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD4547
- •Previous history of retinal pigmented epithelial detachment RPED, previous laser treatment or intra-ocular injection for macular degeneration previous history of retinal vein occlusion (RVO) and retinal degenerative disease or any relevant other clinically relevant chorioretinal defect
- •Any investigational agents or study drugs from a previous clinical study within 30 days before the first dose of study treatment
- •Any chemotherapy, anticancer immunotherapy or anticancer agents within 4 weeks (6 weeks for nitrosourea) before the first dose of study treatment,
- •Potent inhibitors or inducers of CYP3A4 or 2D6 or substrates of CYP3A4 within the required washout period
- •Prior exposure to AZD4547 or any other anti-FGFR drug
研究者
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