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First received: March 07, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Endometrial Cancer

Study Type: INTERVENTIONAL


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

Brief Summary: 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.

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