The assumption would be it has no chance to achieve the primary outcome measure compared to he controls, which is "time to death from any cause":
Primary Outcome Measures :
Overall Survival (OS) [ Time Frame: From date of randomization until the date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first. ]
Overall survival is defined from the time of randomization to death from any cause. Patients still alive at the time of an analysis will be considered censored at their date of last contact.
But the patients will continued to be followed until completion as not all will have died yet. Just too many to have any possibility to meet the primary end point. That gives a chance still that something may turn up from a secondary outcome measures (PFS, tumor response and duration of response), BUT unfortunately it won't help with approval or commercial sales.
Secondary Outcome Measures :
Progression-free survival (PFS) [ Time Frame: From date of randomization to date of clinically determined progression or date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first. ]
Progression-free survival is defined as the time from randomization to clinically determined progression or death from any cause. All participants will be included in the analysis of PFS.
Tumor Response [ Time Frame: From initiation of study treatment to date of disease progression, or until 12 months following last patient randomization (approximately 2 years), whichever comes first. ]
Tumor response is categorized by Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Response captured from initiation of study treatment until disease progression.
Duration of Response (CR + PR) [ Time Frame: From date of response to date of clinically determined disease progression or date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first. ]
Duration of response (CR+PR) is defined as time from date of response to date of clinically determined disease progression or death from any cause.
KZA Price at posting:
24.0¢ Sentiment: Hold Disclosure: Held