A Phase I, open-label, dose escalation study of LDK378 in pediatric patients with malignancies that have a genetic alteration in anaplastic lymphoma kinase (ALK) - Phase I study of LDK378 in pediatric malignancies with a genetic alteration in ALK

ovartis Pharma Services AG0 个研究点目标入组 83 人开始时间: 2013年5月8日最近更新: 2020年11月3日

研究概览

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•- Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
•- Age = 12 months and < 18 years
•- The tumor must carry a genetic alteration of ALK
•- Patients must have evaluable or measurable disease
•Other protocol-defined inclusion criteria may apply
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 80
•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

•- Symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy (such as radiotherapy, surgery or intrathecal chemotherapy) to control their CNS disease
•- Clinically significant, uncontrolled heart disease
•- Inadequate end organ function as defined by specified laboratory values
•- Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
•- Use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study.
•-History of interstitial lung disease or interstitial pneumonitis, including
•clinically significant radiation pneumonitis
•- Medications with a known risk of prolongation of QT interval
•-Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
•Other protocol-defined exclusion criteria may apply

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