EUCTR2010-019348-37-GB进行中（未招募）1 期
A phase I/II study of LDE225 in pediatric patients with recurrent or refractory medulloblastoma or other tumors potentially dependent on the Hedgehog-signaling pathway and adult patients with recurrent or refractory medulloblastoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
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 = 12 months and < 18 years
- •- Histologically confirmed diagnosis of MB, rhabdomyosarcoma, neuroblastoma, hepatoblastoma, high-grade glioma, or osteosarcoma that has progressed despite treatment with standard therapies, or for which no standard treatments are available (patients with brainstem gliomas are excluded from this study)
- •- Adequate renal function
- •- Adequate liver function
- •- Adequate bone marrow function
- •- Women of child-bearing potential must be using two forms of highly effective methods of contraception throughout the study and for 6 months after the last study treatment.
- •- Sexually active males must use a condom during intercourse while taking LDE225 and for 6 months after stopping LDE225 treatment
- •- Patients aged = 12 months
- •- Histologically confirmed diagnosis of recurrent or refractory MB,
- •- At least one measureable lesion
- •- Adequate renal function
- •- Adequate liver function
- •- Adequate bone marrow function
- •- Women of child-bearing potential must be using two forms of highly effective methods of contraception throughout the study and for 6 months after the last study treatment.
- •- Sexually active males must use a condom during intercourse while taking LDE225 and for 6 months after stopping LDE225 treatment
- •Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 85
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Systemic anticancer treatment within 2 weeks before first dose of study
- •- Focal radiation therapy within 4 weeks before first dose of study treatment, or full spinal radiotherapy within 3 months of first dose of study treatment.
- •- Investigational agents within 2 weeks or = 5 x t1/2 (whichever is longer) before start of study therapy.
- •- Unresolved toxicity greater than CTCAE grade 1 from previous anticancer therapy or radiation therapy, or incomplete recovery from previous surgeryPatients 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
- •- Major surgery, serious illness, or traumatic injury within 2 weeks of starting study therapy. Patients anticipated to require major surgery within the first 2 cycles of treatment.
- •- Patients who require a nasogastric tube for drug administration
- •- 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.
- •- Patients who have neuromuscular disorders that are associated with elevated CK
- •- Impaired cardiac function or clinically significant heart disease,
- •- Pregnant or nursing (lactating) females.
- •- Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B or C
- •- Impairment of GI function or GI disease
- •- Patients on concomitant treatment with drugs that are recognized to cause rhabdomyolysis,
- •- Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment.
- •Other protocol defined exclusion criteria may apply.
研究者
相似试验
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