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New treatment option for Endometrial Cancer
Official title Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
ClinicalTrials.gov ID: NCT05797831
What this study is testing
What is Navtemadlin?
Navtemadlin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for endometrial cancer.
Also referred to as KRT-232.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- ECOG 0-1
- Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
- people with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR...
- Adequate hematologic, hepatic and renal function (within 14 days)
You likely can't join if
- Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
- Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)
- Indwelling surgical drains
- Grade 2 or higher QTc prolongation
- History of major organ transplant
- History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)
The study team makes the final eligibility decision.
Where it's taking place
- Vallejo, California, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Hinsdale, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Silver Spring, Maryland, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- West Islip, New York, United States
- Pinehurst, North Carolina, United States
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
- Austin, Texas, United States
- Fort Worth, Texas, United States
- San Antonio, Texas, United States
- Graz, Austria
+ 59 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vallejo, California, United States; Atlanta, Georgia, United States; Savannah, Georgia, United States; Hinsdale, Illinois, United States; Fort Wayne, Indiana, United States; Indianapolis, Indiana, United States and 73 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.