{"groups":[{"description":"Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.","id":"FG000","title":"Treatment (Larotrectinib [LOXO-101])"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Ineligible"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Mutation Status Not Confirmed"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"8"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Still on Therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"16"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"16"}],"type":"Started Protocol Therapy"},{"achievements":[{"groupId":"FG000","numSubjects":"15"}],"type":"Eligible"},{"achievements":[{"groupId":"FG000","numSubjects":"12"}],"comment":"Primary efficacy analysis set","type":"Eligible, Treated and Mutation Status Confirmed"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"16"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Patients were assigned to subprotocol Z1E if an NTRK fusion-positive tumor was identified. The mutation status was determined by an NCI-MATCH approved laboratory for all 16 patients in this arm. These cases had to be confirmed to be used in primary analysis.","recruitmentDetails":"Subprotocol Z1E was activated on March 13, 2017. Between August 21, 2017, and July 8, 2021, 16 patients were enrolled in subprotocol Z1E. All were enrolled on the basis of the outside assay results."}