{"groups":[{"description":"Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG000","title":"P1B ST: CFZ 20 mg/m² Bolus"},{"description":"Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG001","title":"P1B ST: CFZ 20/27 mg/m² Bolus"},{"description":"Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG002","title":"P1B ST: CFZ 20/36 mg/m² Bolus"},{"description":"Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG003","title":"P2 ST: CFZ 20/36 mg/m² Bolus"},{"description":"Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG004","title":"P1B ST: CFZ 36 mg/m²"},{"description":"Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG005","title":"P1B ST: CFZ 45 mg/m²"},{"description":"Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG006","title":"P1B ST: CFZ 20/45 mg/m²"},{"description":"Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG007","title":"P1B ST: CFZ 20/56 mg/m²"},{"description":"Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG008","title":"P1B ST: CFZ 20/70 mg/m²"},{"description":"Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG009","title":"P1B MM: CFZ 20/36 mg/m²"},{"description":"Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG010","title":"P1B MM: CFZ 20/45 mg/m²"},{"description":"Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG011","title":"P1b MM: CFZ 20/56 mg/m²"},{"description":"Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG012","title":"P1B MM: CFZ 20/70 mg/m²"},{"description":"Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG013","title":"P1B LYM: CFZ 20/56 mg/m²"},{"description":"Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG014","title":"P1B LYM: CFZ 20/70 mg/m²"},{"description":"Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG015","title":"P1B MM: CFZ 20/45 mg/m² + Dex"},{"description":"Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.","id":"FG016","title":"P1B MM: CFZ 20/56 mg/m² + Dex"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"42"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"4"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"6"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"3"},{"groupId":"FG011","numSubjects":"14"},{"groupId":"FG012","numSubjects":"2"},{"groupId":"FG013","numSubjects":"1"},{"groupId":"FG014","numSubjects":"2"},{"groupId":"FG015","numSubjects":"11"},{"groupId":"FG016","numSubjects":"5"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"3"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"5"},{"groupId":"FG012","numSubjects":"0"},{"groupId":"FG013","numSubjects":"1"},{"groupId":"FG014","numSubjects":"1"},{"groupId":"FG015","numSubjects":"0"},{"groupId":"FG016","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"3"},{"groupId":"FG012","numSubjects":"0"},{"groupId":"FG013","numSubjects":"1"},{"groupId":"FG014","numSubjects":"0"},{"groupId":"FG015","numSubjects":"1"},{"groupId":"FG016","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"2"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"2"},{"groupId":"FG012","numSubjects":"0"},{"groupId":"FG013","numSubjects":"0"},{"groupId":"FG014","numSubjects":"1"},{"groupId":"FG015","numSubjects":"0"},{"groupId":"FG016","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"65"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"6"},{"groupId":"FG007","numSubjects":"10"},{"groupId":"FG008","numSubjects":"11"},{"groupId":"FG009","numSubjects":"4"},{"groupId":"FG010","numSubjects":"3"},{"groupId":"FG011","numSubjects":"24"},{"groupId":"FG012","numSubjects":"2"},{"groupId":"FG013","numSubjects":"3"},{"groupId":"FG014","numSubjects":"7"},{"groupId":"FG015","numSubjects":"14"},{"groupId":"FG016","numSubjects":"8"}],"type":"STARTED"},{"achievements":[{"comment":"Indicates participants who completed 12 cycles of study drug","groupId":"FG000","numSubjects":"0"},{"comment":"Indicates participants who completed 12 cycles of study drug","groupId":"FG001","numSubjects":"0"},{"comment":"Indicates participants who completed 12 cycles of study drug","groupId":"FG002","numSubjects":"1"},{"comment":"Indicates participants who completed 12 cycles of study drug","groupId":"FG003","numSubjects":"2"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG004","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG005","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG006","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG007","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG008","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG009","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG010","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG011","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG012","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG013","numSubjects":"0"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG014","numSubjects":"3"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG015","numSubjects":"2"},{"comment":"Indicates participants receiving treatment as of the data cut-off date of 07 October 2014","groupId":"FG016","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"63"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"6"},{"groupId":"FG007","numSubjects":"10"},{"groupId":"FG008","numSubjects":"11"},{"groupId":"FG009","numSubjects":"4"},{"groupId":"FG010","numSubjects":"3"},{"groupId":"FG011","numSubjects":"24"},{"groupId":"FG012","numSubjects":"2"},{"groupId":"FG013","numSubjects":"3"},{"groupId":"FG014","numSubjects":"4"},{"groupId":"FG015","numSubjects":"12"},{"groupId":"FG016","numSubjects":"8"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Phase 1b followed a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD). For Phase 2 (bolus), a Simon 2-stage design was planned using the MTD from phase 1b. The first stage of the Simon's 2-stage design was carried out; however, the study did not progress to the second stage.","recruitmentDetails":"Patients with relapsed solid tumors (non-small and small cell lung, ovarian, renal, any other solid tumor type), multiple myeloma or lymphoma were enrolled at 7 sites in the US.\n\nUnder the original protocol patients received a bolus intravenous (IV) infusion of carfilzomib; patients enrolled under Amendments 2 to 4 received a 30-minute IV infusion."}