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NCT05797831 · ClinicalTrials.gov record · last posted 2024-05-02

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

StatusRecruiting
PhasePhase 2/3
Started2023-07-17
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 2, 2024 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.

Amendment record 8 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 8 times since 2023-03-21; most recent amendment 2024-04-30. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-08-03
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT05797831
Lead Sponsor Kartos Therapeutics, Inc.
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Conditions Endometrial Cancer
Enrollment 268 participants
Start Date 2023-07-17
Primary Completion 2025-08 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2024-05-02