{"groups":[{"description":"Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.","id":"FG000","title":"Phase I - Dose Level 0"},{"description":"Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.","id":"FG001","title":"Phase I - Dose Level 1"},{"description":"Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.","id":"FG002","title":"Phase I - Dose Level 2"},{"description":"Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.","id":"FG003","title":"Phase II - Analysis Group 1 Pazopanib"},{"description":"Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.","id":"FG004","title":"Phase II - Analysis Group 1 MLN0128"},{"description":"Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.","id":"FG005","title":"Phase II - Analysis Group 2 Pazopanib"},{"description":"Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.","id":"FG006","title":"Phase II - Analysis Group 2 MLN0128"},{"description":"Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.","id":"FG007","title":"Phase II - Analysis Group 1 Pazopanib Crossover"},{"description":"Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.","id":"FG008","title":"Phase II - Analysis Group 2 Pazopanib Crossover"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"Did not meet eligibility criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"Withdrew before initiation of regimen"}],"milestones":[{"achievements":[{"comment":"Pre-registered","groupId":"FG000","numSubjects":"4"},{"comment":"Pre-registered","groupId":"FG001","numSubjects":"4"},{"comment":"Pre-registered","groupId":"FG002","numSubjects":"4"},{"comment":"Randomized","groupId":"FG003","numSubjects":"6"},{"comment":"Randomized","groupId":"FG004","numSubjects":"13"},{"comment":"Randomized","groupId":"FG005","numSubjects":"15"},{"comment":"Randomized","groupId":"FG006","numSubjects":"56"},{"comment":"Randomized","groupId":"FG007","numSubjects":"6"},{"comment":"Randomized","groupId":"FG008","numSubjects":"43"}],"type":"STARTED"},{"achievements":[{"comment":"Registered","groupId":"FG000","numSubjects":"3"},{"comment":"Registered","groupId":"FG001","numSubjects":"3"},{"comment":"Registered","groupId":"FG002","numSubjects":"3"},{"comment":"Received treatment; included in safety analysis","groupId":"FG003","numSubjects":"6"},{"comment":"Received treatment; included in safety analysis","groupId":"FG004","numSubjects":"12"},{"comment":"Received treatment; included in safety analysis","groupId":"FG005","numSubjects":"13"},{"comment":"Received treatment; included in safety analysis","groupId":"FG006","numSubjects":"55"},{"comment":"Received treatment; included in safety analysis","groupId":"FG007","numSubjects":"6"},{"comment":"Received treatment; included in safety analysis","groupId":"FG008","numSubjects":"43"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Initial Treatment (Up to 4 Months)"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"comment":"PD on pazopanib","groupId":"FG007","numSubjects":"6"},{"comment":"PD on pazopanib","groupId":"FG008","numSubjects":"43"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"comment":"Initiated crossover to MLN0128 following PD on pazopanib","groupId":"FG007","numSubjects":"4"},{"comment":"Initiated crossover to MLN0128 following PD on pazopanib","groupId":"FG008","numSubjects":"26"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"17"}],"type":"NOT COMPLETED"}],"title":"Optional Crossover (Up to 2 Months)"}],"preAssignmentDetails":"Phase II Analysis Group 1: 32 Patients pre-registered; 7 did not pass screening, leaving 25 to proceed to randomization.\n\nPhase II Analysis Group 2: 166 Patients pre-registered; 52 did not pass screening, leaving 114 to proceed to randomization."}