Phase I: dose-escalating portion with the starting dose of amrubicin at 90mg/m^2 IV q21 days.\nDose escalations are as follows:
DL2 - 100mg/m^2; DL3 - 110mg/m^2; and DL4 - 120mg/m^2.\nAll cycles are q21 days
Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days
"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/measure","value":"Progression-Free Survival (PFS) of MTD/Phase II Patients"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/description","value":"Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study.\nProgression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/description","value":"Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","value":"every 6 weeks until treatment discontinuation, up to 43 months"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/measure","value":"Overall Survival (OS) of MTD/Phase II Patients"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/description","value":"Measured from Day 1 of study drug administration to date of death due to any cause.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to this outcome measure."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","value":"every 6 weeks until treatment discontinuation, up to 43 months"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/description","value":"The number of patients with observed complete response [CR] or partial response [PR].\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","value":"every 6 weeks until treatment discontinuation, up to 43 months"},{"op":"add","path":"/resultsSection/participantFlowModule/groups/4","value":{"description":"Amrubicin - 110 mg/m^2 IV every 21 days","id":"FG004","title":"Phase II"}},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/title","value":"Overall Study"},{"op":"add","path":"/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/4","value":{"groupId":"FG004","numSubjects":"63"}},{"op":"add","path":"/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/4","value":{"groupId":"FG004","numSubjects":"0"}},{"op":"add","path":"/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/4","value":{"groupId":"FG004","numSubjects":"63"}},{"op":"remove","path":"/resultsSection/participantFlowModule/periods/1"},{"op":"remove","path":"/resultsSection/baselineCharacteristicsModule/populationDescription"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/groups/0/title","value":"Phase I - Dose Level 1"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/groups/0/description","value":"Amrubicin -90 mg/m^2 by intravenous(IV) every 21days"},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/groups/1","value":{"description":"Amrubicin -100 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groups","id":"BG005","title":"Total"}},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/denoms/0/counts/0/value","value":"3"},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/denoms/0/counts/1","value":{"groupId":"BG001","value":"3"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/denoms/0/counts/2","value":{"groupId":"BG002","value":"3"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/denoms/0/counts/3","value":{"groupId":"BG003","value":"6"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/denoms/0/counts/4","value":{"groupId":"BG004","value":"63"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/denoms/0/counts/5","value":{"groupId":"BG005","value":"78"}},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/0/title","value":"Age, Categorical"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/0/paramType","value":"COUNT_OF_PARTICIPANTS"},{"op":"remove","path":"/resultsSection/baselineCharacteristicsModule/measures/0/dispersionType"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/0/unitOfMeasure","value":"Participants"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/0/value","value":"0"},{"op":"remove","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/0/lowerLimit"},{"op":"remove","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/0/upperLimit"},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/1","value":{"groupId":"BG001","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/2","value":{"groupId":"BG002","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/3","value":{"groupId":"BG003","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/4","value":{"groupId":"BG004","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/5","value":{"groupId":"BG005","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/title","value":"<=18 years"},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/1","value":{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"44"},{"groupId":"BG005","value":"58"}],"title":"Between 18 and 65 years"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/2","value":{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"19"},{"groupId":"BG005","value":"20"}],"title":">=65 years"}},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/0/value","value":"3"},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/1","value":{"groupId":"BG001","value":"3"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/2","value":{"groupId":"BG002","value":"3"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/3","value":{"groupId":"BG003","value":"6"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/4","value":{"groupId":"BG004","value":"63"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/5","value":{"groupId":"BG005","value":"78"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/1","value":{"groupId":"BG001","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/2","value":{"groupId":"BG002","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/3","value":{"groupId":"BG003","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/4","value":{"groupId":"BG004","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/5","value":{"groupId":"BG005","value":"0"}},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/2/title","value":"Ethnicity (NIH/OMB)"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/2/paramType","value":"COUNT_OF_PARTICIPANTS"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/2/unitOfMeasure","value":"Participants"},{"op":"remove","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/title"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/0/value","value":"0"},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/1","value":{"groupId":"BG001","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/2","value":{"groupId":"BG002","value":"0"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/3","value":{"groupId":"BG003","value":"1"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/4","value":{"groupId":"BG004","value":"3"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/5","value":{"groupId":"BG005","value":"4"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/title","value":"Hispanic or Latino"},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/1","value":{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"53"},{"groupId":"BG005","value":"63"}],"title":"Not Hispanic or Latino"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/2","value":{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"11"}],"title":"Unknown or Not Reported"}},{"op":"add","path":"/resultsSection/baselineCharacteristicsModule/measures/3","value":{"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"}],"title":"American Indian or Alaska Native"},{"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"}],"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"}],"title":"Native Hawaiian or Other Pacific 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Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title","value":"Progression-Free Survival (PFS) of MTD/Phase II Patients"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description","value":"Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study.\nProgression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/populationDescription","value":"Patients who received the dose level 3 MTD dose/Phase II dose (Amrubicin -110 mg/m^2) are included in the analysis.\nThe 3, dose level 3 phase I pts and 63 phase II pts treated at this dose level are all combined to evaluate the efficacy of the MTD/phase II dose.\nThe phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.\nThe other 12 phase I pts who were not treated at the MTD are excluded."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description","value":"Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events 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or later phase II) is not relevant to the outcome measure.\nThe other 12 phase I pts who were not treated at the MTD are excluded."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame","value":"every 6 weeks until treatment discontinuation, up to 43 months"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description","value":"The number of patients with observed complete response [CR] or partial response [PR].\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription","value":"Patients who received the dose level 3 MTD dose/Phase II dose (Amrubicin -110 mg/m^2) are included in the analysis.\nThe 3, dose level 3 phase I pts and 63 phase II pts treated at this dose level are all combined to evaluate the efficacy of the MTD/phase II dose.\nThe phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.\nThe other 12 phase I pts who were not treated at the MTD are excluded."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame","value":"every 6 weeks until treatment discontinuation, up to 43 months"},{"op":"replace","path":"/resultsSection/adverseEventsModule/description","value":"All patients who received at least one dose of protocol treatment were followed for safety.\nAdverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0"},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/title","value":"Dose Level 1"},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/description","value":"Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 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