Navtemadlin for maintenance therapy in advanced endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the use of navtemadlin as a maintenance treatment for patients with advanced or recurrent endometrial cancer who have shown a complete or partial response to prior chemotherapy. The trial is divided into two parts: the first part assesses the safety and efficacy of two different doses of navtemadlin compared to an observational control arm, while the second part compares the selected Phase 3 dose of navtemadlin to a placebo. The goal is to determine the optimal dosing and effectiveness of navtemadlin in prolonging patient responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ECOG 0-1
* Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
* Subjects 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 per RECIST V1.1
* Adequate hematologic, hepatic and renal function (within 14 days)

Exclusion Criteria:

* 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)

Where it's running

• Kaiser Permanente Center
  Vallejo, California, United States Recruiting
• Northside Hospital
  Atlanta, Georgia, United States Recruiting
• St. Joseph
  Savannah, Georgia, United States Recruiting
• Dr. Sudarshan K. Sharma, Ltd.
  Hinsdale, Illinois, United States Recruiting
• Parkview Research Center
  Fort Wayne, Indiana, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting

+33 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: John Mei
• Email: jmei@kartosthera.com
• Phone: 650-542-0136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.