{"denoms":[{"counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"4"},{"groupId":"BG008","value":"5"},{"groupId":"BG009","value":"3"},{"groupId":"BG010","value":"13"},{"groupId":"BG011","value":"1"},{"groupId":"BG012","value":"1"},{"groupId":"BG013","value":"64"}],"units":"Participants"}],"groups":[{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG000","title":"Cohort A1 DL1"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG001","title":"Cohort A1 DL2"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG002","title":"Cohort A1 DL3"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG003","title":"Cohort A1 DL4"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG004","title":"Cohort A1 DL5"},{"description":"Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG005","title":"Cohort A2 DL 3A"},{"description":"Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG006","title":"Cohort A2 DL4A"},{"description":"Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG007","title":"Cohort A2 DL4A Expansion"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"BG008","title":"Cohort B1 DL5"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.\n\nCyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle\n\nTopotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle\n\nFilgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \\> 2000/mm\\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.\n\nPegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.","id":"BG009","title":"Cohort B2 DL4B"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.\n\nCyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle\n\nTopotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle\n\nFilgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \\> 2000/mm\\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.\n\nPegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.","id":"BG010","title":"Cohort B2 DL5B"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.\n\nCyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle\n\nTopotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle\n\nFilgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \\> 2000/mm\\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.\n\nPegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.","id":"BG011","title":"Cohort B2 DL3A"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days at 150mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.\n\nCyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle\n\nTopotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle\n\nFilgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \\> 2000/mm\\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.\n\nPegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.","id":"BG012","title":"Cohort B2 DL4A"},{"description":"Total of all reporting groups","id":"BG013","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"2"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"5"},{"groupId":"BG009","value":"3"},{"groupId":"BG010","value":"13"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"48"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"4"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"1"},{"groupId":"BG012","value":"1"},{"groupId":"BG013","value":"16"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"0"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"3"},{"groupId":"BG007","value":"3"},{"groupId":"BG008","value":"2"},{"groupId":"BG009","value":"1"},{"groupId":"BG010","value":"7"},{"groupId":"BG011","value":"1"},{"groupId":"BG012","value":"1"},{"groupId":"BG013","value":"35"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"2"},{"groupId":"BG006","value":"3"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"2"},{"groupId":"BG010","value":"6"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"29"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"4"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"2"},{"groupId":"BG008","value":"5"},{"groupId":"BG009","value":"3"},{"groupId":"BG010","value":"11"},{"groupId":"BG011","value":"1"},{"groupId":"BG012","value":"1"},{"groupId":"BG013","value":"56"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"2"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"4"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"4"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"1"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"1"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"5"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"3"},{"groupId":"BG008","value":"1"},{"groupId":"BG009","value":"2"},{"groupId":"BG010","value":"8"},{"groupId":"BG011","value":"1"},{"groupId":"BG012","value":"1"},{"groupId":"BG013","value":"45"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"1"},{"groupId":"BG010","value":"4"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"10"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}],"populationDescription":"65 patients are included in the initial participant flow as 65 patients were enrolled on this protocol. However, 1 patient was determined to be ineligible prior to start of protocol therapy. The 64 patients included in the baseline analysis population represent all eligible enrolled patients on this protocol."}