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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: Recruiting Phase 2 study of Endometrial Cancer, sponsored by Kartos Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
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 |
What NCT05797831 shows while recruiting
NCT05797831 is an interventional study that assigns participants to a tested intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (49% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Endometrial Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05797831's enrollment target sits among peer trials
268 53rd of 181 higher than 129 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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