Brustzentrum St. Joseph-Stift Bremen Schwachhauser Heerstraße 54 28209 Bremen DeutschlandRekrutierend» Google-MapsKaiser Permanente Center 94589 Vallejo United StatesRekrutierend» Google-MapsNorthside Hospital 30342 Atlanta United StatesRekrutierend» Google-Maps
Dr. Sudarshan K. 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1. 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
2. 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
Secondary outcome:
1. Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment (Time Frame - 50 months): PFS defined as the time from randomization to disease progression by IRC/investigator assessment or death, whichever occurs first
2. Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST) (Time Frame - 50 months): TFST defined as the time from randomization to initiation of first subsequent anticancer therapy or death, whichever occurs first
3. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin (Time Frame - 1 day): Will determine the Maximum observed concentration (Cmax)
4. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin (Time Frame - 1 day): Will determine the area under the plasma concentration versus time curve (AUC)
5. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin (Time Frame - 1 day): Will determine the time of maximum plasma concentration (Tmax)
6. Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR) (Time Frame - 50 months): Best response of complete response (CR), partial response (PR) or stable disease (SD) by IRC/investigator assessment among subjects with PR as best response from prior chemotherapy