A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects with TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

Advanced or Recurrent Endometrial Cancer

Part 1: Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1. Part 2: PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first

Part 1: PFS defined as the time from randomization to disease progression by IRC/investigator assessment or death, whichever occurs first, Part 2: - PFS defined as the time from randomization to disease progression by investigator assessment or death, whichever occurs first. - TFST defined as the time from randomization to initiation of first subsequent anti-cancer therapy or death, whichever occurs first., Part 1&2: OS defined as the time from randomization to death of any cause, Part 1&2: IRC/investigator assessed response per RECIST 1.1 (Appendix 4 of the protocol), Part 1&2: 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, Part 1&2: Navtemadlin and acyl glucuronide metabolite (M1) PK parameters, including but not limited to: • Maximum observed concentration (Cmax) • Time to maximum plasma concentration (Tmax) • Area under the plasma concentration-time curve (AUC), Part 1&2: • Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs) • Changes in laboratory values, electrocardiograms (ECGs) and vital signs

No related papers found yet.

Austria, Czechia, Denmark, Estonia, Finland, France, Hungary, Italy, Lithuania, Norway, Poland, Romania, Slovenia, Spain, Sweden