Primary Outcome Measures
Progression-Free Survival (PFS) [Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months] [Designated as safety issue: ]
Secondary Outcome Measures
Objective Response Rate (ORR) [Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months] [Designated as safety issue: ]
Duration of Response (DOR) [Time Frame: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months] [Designated as safety issue: ]
Clinical Benefit Rate (CBR) [Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months] [Designated as safety issue: ]
Overall Survival (OS) [Time Frame: From randomization up to death from any cause, up to approximately 53 months] [Designated as safety issue: ]
Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score [Time Frame: From Day 1 of Cycle 1 up to approximately 53 months] [Designated as safety issue: ]
Time to Deterioration in Pain [Time Frame: From Day 1 of Cycle 1 up to approximately 53 months] [Designated as safety issue: ]
Incidence and Severity of Adverse Events (AEs) [Time Frame: From randomization up to approximately 53 months] [Designated as safety issue: ]
Changes in Vital Signs [Time Frame: From randomization up to approximately 53 months] [Designated as safety issue: ]
Changes in Targeted Laboratory Results [Time Frame: From randomization up to approximately 53 months] [Designated as safety issue: ]
Plasma Concentration of Ipatasertib and Its Metabolite (G-037720) [Time Frame: Day 1 and Day 15 of Cycle 1, and on Day 15 of Cycle 3] [Designated as safety issue: ]