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) - CLDK378X2103

ovartis0 sites6 target enrollmentStarted: TBDLast updated: April 29, 2024

Study Overview

No summary available.

•- 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

•- 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;- History of known of interstitial lung disease or interstitial pneumonitis, including
•clinically significant radiation pneumonitis (i.e., affecting activities of daily living or
•requiring therapeutic intervention).;-Radiotherapy to lungs * 4 weeks prior to starting the study treatment or
•patients who have not recovered from radiotherapy related toxicities. For
•all other anatomic sites, radiotherapy * 2 weeks prior to starting the study treatment.;- 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.;- 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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