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Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
NCT05797831 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2023-07-17 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05797831
The ClinicalTrials.gov registry entry for NCT05797831 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kartos Therapeutics, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05797831 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, Georgia, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05797831?
The interventions under investigation include: Navtemadlin (DRUG), Navtemadlin Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05797831?
This trial is sponsored by Kartos Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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