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A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
Primary Outcome Measures :
Part 1: To determine the navtemadlin Phase 3 dose [ Time Frame: 12 months ]
Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo [ Time Frame: 50 months ]
PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first
Primary Outcome Measures :
Part 1: To determine the navtemadlin Phase 3 dose [ Time Frame: 12 months ]
Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo [ Time Frame: 50 months ]
PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first
Recruitment Status
Past Studies