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

NCT05797831 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2024-05-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Navtemadlin

Navtemadlin is an experimental MDM2 anticancer drug taken by mouth

DRUG

Navtemadlin Placebo

Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • GOG Foundation

    collaborator NETWORK

  • Kartos Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2025-08-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Denmark
  • Estonia
  • Finland
  • Georgia
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Norway
  • Poland
  • Romania
  • Slovenia
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797831 on ClinicalTrials.gov