Endometrial Cancer study: Navtemadlin
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 oral medicine being studied as a maintenance treatment for advanced or recurrent endometrial cancer. Navtemadlin is designed to inhibit the MDM2 protein, which may help activate the p53 tumor suppressor pathway.
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
- The study wants to see if navtemadlin is safe and helps keep cancer from coming back after chemotherapy. It will compare two doses and then test the best dose against a placebo.
- Who it's for
- It is looking for adults who have advanced or recurrent endometrial cancer and who have had a complete or partial response to chemotherapy.
- What's involved
- Participants will receive either navtemadlin at one of two doses or a placebo, and will have regular clinic visits and tests to monitor safety and cancer status.
- Time commitment
- The study lasts about 2 years, with visits every few weeks for the first months and then every few months thereafter.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.