| Primary | Number of Participants With Dose-Limiting Toxicity (DLT) | DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:1. Grade 4 neutropenia lasting ≥7 consecutive days, 2. Grade 4 neutropenia with fever and/or infection 3. Platelet count <25,000/mm^3 4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis 5. Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide 6. Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (<1 week) Grade 3 fatigue 7. Treatment delay of >21 days due to failure of adequate hematologic or non-hematologic recovery from previous cycle of treatment 8. Other alisertib related non-hematologic toxicities ≥Grade 2 that, in the opinion of the investigator required a dose reduction or discontinuation of therapy with alisertib. | DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred. | Posted | | Number | | participants | | From first dose of study drug to 30 days after the last dose (up to 422 days) | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG003 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG004 | Alisertib 65 mg PIC QD 14D | Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Maximum Tolerated Dose (MTD) of Alisertib | MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants. | DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred. | Posted | | Number | | mg BID for 7 days | | From first dose of study drug to 30 days after the last dose (up to 422 days) | | | | ID | Title | Description |
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| OG000 | Alisertib | Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1 | | Pharmacokinetic (PK) evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM | | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM | | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Median | Full Range | hours (h) | | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Median | Full Range | h | | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM*h | | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Terminal Half-Life (t1/2) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h | | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ratio | | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis, with data available at the given time point. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ratio | | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis, with data available at the given time point. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 25mg PIC QD 21D | Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 35 mg PIC QD 21D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM | | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 65 mg PIC QD 14D | |
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| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 65 mg PIC QD 14D |
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| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | Posted | | Median | Full Range | h | | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 65 mg PIC QD 14D | Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Median | Full Range | h | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 65 mg PIC QD 14D |
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| Primary | AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM*h | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 |
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| Primary | Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ratio | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 65 mg PIC QD 14D |
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| Primary | Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | Posted | | Mean | Standard Deviation | ratio | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 65 mg PIC QD 14D | Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 35 mg PIC QD 14D | Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 45 mg PIC QD 14D | Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 65 mg PIC QD 14D | |
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| Primary | Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM | | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | | | | ID | Title | Description |
|---|
| OG000 | Alisertib 40 mg ECT QD 14D | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
|---|
| OG000 | Alisertib 40 mg ECT QD 14D | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | Posted | | Median | Full Range | h | | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | | | | ID | Title | Description |
|---|
| OG000 | Alisertib 40 mg ECT QD 14D | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | | Median | Full Range | h | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
|---|
| OG000 | Alisertib 40 mg ECT QD 14D | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM*h | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 40 mg ECT QD 14D | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Terminal Half Life for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 40 mg ECT QD 14D | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Peak/Trough Ratio for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ratio | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 40 mg ECT QD 14D | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | L/h | | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 40 mg ECT QD 14D | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM | | Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D | Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM | | Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D | |
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| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Median | Full Range | h | | Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D | Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Median | Full Range | h | | Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D | Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM*hr | | Cycle 1 Days 1 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D |
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| Primary | AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nM*hr | | Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D |
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| Primary | Terminal Half-Life (t1/2) for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h | | Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D | Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Accumulation Ratio (Rac) for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ratio | | Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D | Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | Peak/Trough Ratio for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ratio | | Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D | Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Primary | CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7 | | PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose | | | | ID | Title | Description |
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| OG000 | Alisertib 30 mg ECT BID 7D | Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG001 | Alisertib 40 mg ECT BID 7D | alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). | | OG002 | Alisertib 50 mg ECT BID 7D | |
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| Secondary | Best Overall Response Rate Based on Investigator's Assessment | Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions. | The response-evaluable population is defined as all participants who received at least 1 dose of alisertib and have measurable disease at baseline and have at least 1 post baseline response assessment. | Posted | | Number | | percentage of participants | | Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days) | | | | ID | Title | Description |
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| OG000 | Part 1: PIC Dose Escalation | Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment. | | OG001 | Part 1: ECT Dose Escalation | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles). |
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| Secondary | Duration of Response (DOR) | DOR is defined as the time from the date of first documentation of a response (either CR or PR) to the date of first documentation of progressive disease (PD) according to International Working Group (IWG) criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. | Participants from the Response-Evaluable Population who had a response of CR or PR. | Posted | | Median | Full Range | months | | Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days) | | | | ID | Title | Description |
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| OG000 | Part 1: PIC Dose Escalation | Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment. | | OG001 | Part 1: ECT Dose Escalation | Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles). |
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| Secondary | Number of Participants With Polymorphisms in Gene Encoding Enzyme UGT1A1 | One peripheral blood sample (approximately 4 mL) was to be obtained on Day 1 of Cycle 1 prior to the first dose of alisertib to genotype participants for polymorphisms in UGT1A1 because UGT1A1 is one of the enzymes responsible for glucuronidation of alisertib, which is expected to contribute to the clearance of alisertib. wt=wild type. *28=polymorphism in the promoter region of a UGT1A1 allele resulting in reduced UGT1A1 expression. Not determined = blood sample was not evaluable. | Safety population included all participants who received any amount of study drug. Data is presented for one arm because the data was collected prior to the participant receiving their assigned treatment. | Posted | | Number | | participants | | Cycle 1 Day 1 predose | | | | ID | Title | Description |
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| OG000 | Alisertib | Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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| Secondary | Number of Participants With Polymorphisms in Aurora A Kinase | | As per protocol amendment, no data was collected for polymorphisms in Aurora A Kinase. | Posted | | | | | | Cycle 1 Day 1 predose | | | | ID | Title | Description |
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| OG000 | Alisertib | Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose). |
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