APEC1621E: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)- PHASE 2 SUBPROTOCOL OF SELUMETINIB (AZD6244 HYDROGEN SULFATE) IN PATIENTS WITH TUMORS HARBORING ACTIVATING MAPK PATHWAY MUTATIONS

Brief description of study

This is a phase 2 trial of selumetinib (AZD6244 hydrogen sulfate) in children with recurrent or refractory solid tumors, CNS tumors, non-Hodgkin lymphomas and histiocytic disorders harboring specific activating mutations that result in pathologic activation of the MAPK pathway. Patients will receive selumetinib (AZD6244 hydrogen sulfate) for 28-day cycles at the MTD and recommended Phase 2 dose (RP2D) of 25 mg/m2/dose BID. The primary aim of this trial will be to establish the objective response rate to selumetinib (AZD6244 hydrogen sulfate). While there will not be multiple pre-determined mutation-based cohorts, responses will be analyzed retrospectively with respect to specific MAPK pathway activating mutations.


Clinical Study Identifier: s17-01739
ClinicalTrials.gov Identifier: NCT03213691
Principal Investigator: Sharon L Gardner
Currently Recruiting

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