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NCT05797831 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Endometrial Cancer, sponsored by Kartos Therapeutics.

Recruiting
Registry status
Phase 2
Development phase
268
Enrollment target
20
Study locations

NCT05797831 is a Phase 2 study of Endometrial Cancer that is actively recruiting participants, run by Kartos Therapeutics. The registered enrollment target is 268 participants, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT05797831, a Phase 2 study of Endometrial Cancer, is actively recruiting participants, sponsored by Kartos Therapeutics.

RECRUITING
Registry status
Phase 2
Development phase
268 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • DRUG Navtemadlin
  • DRUG Navtemadlin Placebo

Study Locations (20)

Texas

  • Texas Oncology-Austin Central - Austin
  • Texas Oncology-Fort Worth Cancer Center - Fort Worth
  • Texas Oncology-San Antonio Medical Center - San Antonio

Georgia

  • Northside Hospital - Atlanta
  • St. Joseph - Savannah

Indiana

  • Parkview Research Center - Fort Wayne
  • Indiana University - Indianapolis

Oregon

  • Oncology Associates of Oregon - Eugene
  • Northwest Cancer Specialists - Portland

California

  • Kaiser Permanente Center - Vallejo

Illinois

  • Dr. Sudarshan K. Sharma, Ltd. - Hinsdale

Maryland

  • Maryland Oncology Hematology, P.A. - Silver Spring

Minnesota

  • Minnesota Oncology Hematology, P.A. - Minneapolis

Trial Details

FieldValue
Enrollment Target 268 participants
Start Date 2023-07-17
Est. Completion 2027-07
Phase Phase 2

Sponsor

Kartos Therapeutics

8 total trials

What the Registry Record Tells You About NCT05797831

The ClinicalTrials.gov registry entry for NCT05797831 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (49% lower). The listed sponsor is Kartos Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions - of which Navtemadlin is the first listed.

NCT05797831 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Texas, Georgia, Indiana.

Frequently Asked Questions

What is clinical trial NCT05797831 about?

NCT05797831 is a clinical study titled "Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer". 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 ...

What is the current status of trial NCT05797831?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 268 participants. The study started on 2023-07-17. Estimated completion is 2027-07.

What conditions does trial NCT05797831 study?

This clinical trial studies the following conditions: Endometrial Cancer.

What interventions are being tested in trial NCT05797831?

The interventions under investigation include: Navtemadlin (DRUG), Navtemadlin Placebo (DRUG).

Who is sponsoring clinical trial NCT05797831?

This trial is sponsored by Kartos Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05797831 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.