EUCTR2012-003066-40-GB进行中（未招募）1 期
A Phase III, multi-center, open-label, randomized, controlled study of the efficacy and safety of oral LDE225 versus temozolomide in patients with Hh-pathway activated relapsed medulloblastoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
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
- •- Patients aged >= 4 months
- •- Patients with histologically confirmed diagnosis of MB, who have experienced relapse or progression
- •- Only patients with a test result, using the 5-gene Hh signature assay, indicating Hh-pathway activated MB are eligible for this study.
- •- At least one measurable lesion
- •- Adequate renal function
- •- Adequate liver function
- •- Adequate bone marrow function
- •- Serum CK <= 1.5 ULN
- •Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 59
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •- Prior treatment with a Smoothened inhibitor
- •- Systemic anticancer treatment within 2 weeks before first dose of study treatment
- •- Focal radiation therapy within 4 weeks before first dose of study treatment, or full spinal radiotherapy within 3 months before first dose of study treatment.
- •- Patients who have neuromuscular disorders that are associated with elevated CK
- •- Any concurrent severe and/or uncontrolled medical conditions that in the investigator’s opinion could put the patient at greater risk for treatment-related toxicities or confound the interpretation of clinical outcomes.
- •- Impaired cardiac function
- •- Clinically significant heart disease
- •- Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B or C
- •- Impairment of GI function or GI disease
- •- Major surgery, serious illness, or traumatic injury within 2 weeks of first dose of study treatment.
- •- Unresolved toxicity greater than CTCAE grade 1 from previous anticancer therapy
- •- Patients anticipated to require major surgery within the first 8 weeks of treatment
- •- Patients who require a nasogastric tube for drug administration
- •- Patients on concomitant treatment with drugs that are recognized to cause rhabdomyolysis
- •- Patients receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 or are metabolized by CYP2B6 and CYP2C9.
- •- Patients receiving unstable or increasing doses of corticosteroids
- •- Patients receiving treatment with any enzyme-inducing anticonvulsant that cannot be discontinued at least 2 weeks before first dose of study treatment, and for the duration of the study
- •- Investigational agents within 4 weeks or = 5 x t1/2 (whichever is longer) before first dose of study treatment.
- •- Pregnant females.
- •- Patients who are not willing to apply highly effective contraception.
- •- Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment.
- •Other protocol defined exclusion criteria may apply.
研究者
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