{"groups":[{"description":"Patients receive copanlisib 60 mg IV over 60 minutes on days 1, 8, and 15 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 undergo biopsies and blood sample collection on study.","id":"FG000","title":"Treatment (Copanlisib)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Started Protocol Therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"27"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Physician Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"35"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"33"}],"type":"Started Protocol Therapy"},{"achievements":[{"groupId":"FG000","numSubjects":"29"}],"comment":"Primary efficacy analysis set","type":"Eligible, Treated and Mutation Status Confirmed"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"35"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The PTEN mutation status was determined by a CLIA-approved assay performed in NCI-MATCH approved laboratory for all patients in this arm. Thirty-one out of the 35 outside lab patients had their samples centrally confirmed.","recruitmentDetails":"Subprotocol Z1H was activated on June 20, 2018. Thirty-five patients were enrolled between October 2018 and January 2020. All patients were enrolled through the outside laboratory."}