| Primary | Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | | Safety population includes all participants who received any amount of study drug. | Posted | | Number | | participants | | Phase 1: Baseline through 30 days after the last dose of study drug (approximately up to 35 weeks) | | | | ID | Title | Description |
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| OG000 | Phase 1: All Participants | Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity. |
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| Primary | Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE) | | Safety population included all participants who received any amount of study drug. | Posted | | Number | | participants | | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | | | | ID | Title | Description |
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| OG000 | Phase 1: All Participants | Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity. |
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| Primary | Phase 1- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Toxicity evaluated as per NationalCancerInstituteCommonTerminologyCriteria for AEs (NCI CTCAE),version 4.03.DLT=any event related to MLN0264:Grade 4 neutropenia(absolute neutrophil count[ANC]less than[<]500 cells/millimeter[mm]^3); >=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets <25,000/mm^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;>=Grade 3 diarrhea despite optimal supportive care measures;any other >=Grade 3 nonhematologic toxicity except brief(<1 week)Grade 3 fatigue;Inability to start next therapy cycle greater than (>)2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy. | The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT. | Posted | | Number | | participants | | Phase 1: Up to Cycle 1 (3 weeks) | | | | ID | Title | Description |
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| OG000 | Phase 1: All Participants | Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity. |
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| Primary | Phase 1- Number of Participants With Markedly Abnormal Laboratory Values | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation. | Safety population included all participants who received any amount of study drug. | Posted | | Number | | participants | | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | | | | ID | Title | Description |
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| OG000 | Phase 1: All Participants | Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity. |
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| Primary | Phase 1- Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute [bpm]). | Safety population included all participants who received any amount of study drug. | Posted | | Number | | participants | | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | | | | ID | Title | Description |
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| OG000 | Phase 1: All Participants | Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity. |
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| Primary | Phase 1- Recommended Phase 2 Dose (RP2D) | RP2D is maximum tolerated dose(MTD) in study Phase1.MTD was highest dose of MLN0264 given at which <=1 of 6 participants experienced DLTduring Cycle1 of Phase1.DLT=any event related to MLN0264:Grade 4 neutropenia ANC less than<500 cells mm^3;>=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets <25,000/mm^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;>=Grade 3 diarrhea despite optimal supportive care measures;any other >=Grade 3 nonhematologic toxicity except brief(<1 week)Grade 3 fatigue;Inability to start next therapy cycle>2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy. | The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT. | Posted | | Number | | mg/kg | | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | | | | ID | Title | Description |
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| OG000 | Phase 1: All Participants | Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity. |
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| Primary | Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for MLN0264 | | The Pharmacokinetic (PK) evaluable population included all participants who received greater than or equal to (>=1) dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure. | Posted | | Geometric Mean | Standard Deviation | microgram per milliliter (mcg/mL) | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | mcg/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure. | Posted | | Median | Full Range | day | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. | Posted | | Median | Full Range | day | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | day*mcg/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | day*mcg/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | day*mcg/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm as none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | day*mcg/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | mcg/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264 | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm as none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | mcg/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb) | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters. | Posted | | Geometric Mean | Standard Deviation | mcg/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Cmax: Maximum Observed Serum Concentration for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | mcg/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters. | Posted | | Median | Full Range | day | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available. | Posted | | Median | Full Range | day | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | day*mcg/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | day*mcg/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | day*mcg/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | day*mcg/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | mcg/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAb | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | mcg/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE) | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters. | Posted | | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters. | Posted | | Median | Full Range | day | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available. | Posted | | Median | Full Range | day | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | day*ng/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | day*ng/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | day*ng/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | day*ng/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MMAE | | The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: MLN0264 1.2 mg/kg | MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG001 | Phase 1: MLN0264 1.5 mg/kg | MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity | | OG002 | Phase 1: MLN0264 1.8 mg/kg | MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity |
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| Primary | Phase 2- Overall Response Rate | ORR is the percentage of participants with complete response [CR] + partial response [PR]) based on modified Response Evaluation Criteria in Solid Tumors (RECIST). Overall response rate (CR + PR) based on modified RECIST version 1.1 guidelines. CR: Disappearance of all target lesions and PR: at least a 30 percentage (%) decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. All measurable lesions up to a maximum of 2 lesions per organ, 5 lesions in total representative of all involved organs were identified as target lesions at baseline. Target lesions were selected on the basis of size (longest lesions) and suitability for reproducible repeated measurements. | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Baseline until end of study treatment (approximately 1 year) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 1- Number of Participants With Antitherapeutic Antibodies (ATAs) | Blood samples was collected predose to evaluate ATA. Data was collected only for limited period due to early termination of the study. | Safety population included all participants who received any amount of study drug. | Posted | | Number | | participants | | Day 1 of Cycle 1, 2, 3, 4: predose | | | | ID | Title | Description |
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| OG000 | Phase 1: All Participants | Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity. |
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| Secondary | Phase 1- Disease Response Based on the Investigator's Assessment | Disease response was based on the investigator's assessment using the modified RECIST version 1.1 guidelines. Evaluation of target lesions included CR (Disappearance of all target lesions),PR(at least a 30% decrease in the sum of the LD of target lesions),Progressive disease (PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions) and Stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD).Evaluation of Non target Lesions included CR (disappearance of all non target lesions and normalization of tumor marker level), Incomplete response/SD (Persistence of 1 or more non target lesions and/or maintenance of tumor marker level above the normal limits) and PD(Appearance of 1 or more new lesions and/or unequivocal progression of existing non target lesions). | The Response-Evaluable population is defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 post baseline response assessment. | Posted | | Number | | participants | | Phase 1: Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to End of treatment (EOT) (Cycle10 or week 30) | | | | ID | Title | Description |
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| OG000 | Phase 1: All Participants | Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity. |
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| Secondary | Phase 2- Percentage of Participants Who Experience at Least One TEAE | | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Percentage of Participants Who Experience at Least One SAE | | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Number of Participants With Markedly Abnormal Laboratory Values | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation. | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute [bpm]). | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Progression-free Survival (PFS) | PFS is defined as the time from the date of first study drug administration to the date of first documentation of progressive disease or death. For a participant who has not progressed and is last known to be alive, PFS was censored at the last response assessment that was stable disease or better. PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions. | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Baseline up to EOT, thereafter every 12 weeks until the occurrence of PD, the start of subsequent antineoplastic therapy, or 6 months after discontinuation from treatment, whichever occurs first (total duration of assessment up to 1.5 years) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Duration of Response (DOR) | DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documentation of Progressive Disease (PD). Responders without documentation of PD were censored at the last response assessment that was stable disease or better. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD and PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions. | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to EOT (approximately 1 year) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Disease Control Rate (DCR) | DCR is defined as Complete Response (CR) rate + Partial Response (PR) rate + stable disease (SD) rate with a minimum of 12 weeks' duration. Duration of SD is defined as the time from the date of first study drug administration to the date of first documentation of disease progression for participants who achieved SD as the best overall response. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions) and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Phase 2: Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to EOT (approximately 1 year) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Overall Survival (OS) | OS is defined as the time from the date of first study drug administration to the date of death. Participants without documentation of death at the time of analysis were censored at the date when they were last known to be alive. | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Baseline up to EOT thereafter every 12 weeks until death or the start of subsequent antineoplastic therapy, or 6 months after discontinuation from treatment, whichever occurs first (total duration of assessment up to 1.5 years) | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Plasma Concentration of MLN0264 | | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Day 1 of every cycle (up to 1 year): predose and at multiple time points(up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Tumor Size Reduction | For each participant, the best percentage of tumor reduction from baseline in the sum of the diameter was calculated. | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Baseline up to approximately 1 year | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC) | The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors. The score is obtained by the formula: 3 * percentage of strongly staining nuclei + 2 * percentage of moderately staining nuclei + percentage of weakly staining nuclei, giving a range of 0 to 300. The 600 H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Baseline up to approximately 1 year | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, injection, intravenously on Day 1 of 3 week cycles of Phase 2, until disease progression or unacceptable toxicity. Dosage for this phase was determined from results of Phase 1 MTD/RP2D. |
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| Secondary | Phase 2- Number of Participants With ATA in Serum | Blood samples were to be collected predose to evaluate ATA. | Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations. | Posted | | | | | | Baseline up to approximately 1 year | | | | ID | Title | Description |
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| OG000 | Phase 2: All Participants | MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D. |
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