{"description":"Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the \"AE Other\" table. All-Cause Mortality includes all deaths collected on the study.\n\nIneligible patients are excluded from reporting of adverse events.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Patients receive 165 mg/m\\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Part A Dose Level 1"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Patients receive 215 mg/m\\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)","id":"EG001","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":3,"seriousNumAtRisk":4,"title":"Part A Dose Level 2"},{"deathsNumAffected":1,"deathsNumAtRisk":5,"description":"Patients receive 165 mg/m\\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\\^2 vincristine sulfate IV on day 1, 450 mg/m\\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)","id":"EG002","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":1,"seriousNumAtRisk":5,"title":"Part B Dose Level 1"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Patients receive 215 mg/m\\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\\^2 vincristine sulfate IV on day 1, 450 mg/m\\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)","id":"EG003","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Part B Dose Level 2"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Patients receive 280 mg/m\\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\\^2 vincristine sulfate IV on day 1, 450 mg/m\\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)","id":"EG004","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Part B Dose Level 3"},{"deathsNumAffected":1,"deathsNumAtRisk":4,"description":"Patients receive 165 mg/m\\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.","id":"EG005","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":3,"seriousNumAtRisk":4,"title":"Part C Dose Level 1"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Patients receive 215 mg/m\\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.","id":"EG006","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Part C Dose Level 2"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Patients receive 280 mg/m\\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.","id":"EG007","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Part C Dose Level 3"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Patients receive 165 mg/m\\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.","id":"EG008","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Part D Dose Level 1"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Patients receive 215 mg/m\\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.","id":"EG009","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Part D Dose Level 2"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Patients receive 215 mg/m\\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.","id":"EG010","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Part PK Dose Level 2"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":4},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":1,"numAtRisk":6},{"groupId":"EG009","numAffected":0,"numAtRisk":3},{"groupId":"EG010","numAffected":0,"numAtRisk":3}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":3},{"groupId":"EG004","numAffected":2,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":4},{"groupId":"EG006","numAffected":4,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":3},{"groupId":"EG008","numAffected":4,"numAtRisk":6},{"groupId":"EG009","numAffected":1,"numAtRisk":3},{"groupId":"EG010","numAffected":0,"numAtRisk":3}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition 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partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":4},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":0,"numAtRisk":6},{"groupId":"EG009","numAffected":0,"numAtRisk":3},{"groupId":"EG010","numAffected":0,"numAtRisk":3}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric 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aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":3},{"groupId":"EG004","numAffected":2,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":4},{"groupId":"EG006","numAffected":3,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":3},{"groupId":"EG008","numAffected":0,"numAtRisk":6},{"groupId":"EG009","numAffected":0,"numAtRisk":3},{"groupId":"EG010","numAffected":1,"numAtRisk":3}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":4},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":1,"numAtRisk":6},{"groupId":"EG009","numAffected":0,"numAtRisk":3},{"groupId":"EG010","numAffected":0,"numAtRisk":3}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":4},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":0,"numAtRisk":6},{"groupId":"EG009","numAffected":0,"numAtRisk":3},{"groupId":"EG010","numAffected":0,"numAtRisk":3}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":3},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":4},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":0,"numAtRisk":6},{"groupId":"EG009","numAffected":1,"numAtRisk":3},{"groupId":"EG010","numAffected":0,"numAtRisk":3}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":5},{"groupId":"EG003","numAffected":3,"numAtRisk":3},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":4},{"groupId":"EG006","numAffected":6,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":3,"numAtRisk":6},{"groupId":"EG009","numAffected":2,"numAtRisk":3},{"groupId":"EG010","numAffected":0,"numAtRisk":3}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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