Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Endometrial Cancer
In brief
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.
Key facts
- Study ID
- NCT05797831
- Run by
- Kartos Therapeutics, Inc.
- People needed
- 268
- Starts
- 2023-07-17
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2024-05-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify 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)
Where it is running
- Northside Hospital — Atlanta, Georgia, United States (enrolling)
- St. Joseph — Savannah, Georgia, United States (enrolling)
- Dr. Sudarshan K. Sharma, Ltd. — Hinsdale, Illinois, United States (enrolling)
- Parkview Research Center — Fort Wayne, Indiana, United States (enrolling)
- Indiana University — Indianapolis, Indiana, United States (enrolling)
- Maryland Oncology Hematology, P.A. — Silver Spring, Maryland, United States (enrolling)
- Minnesota Oncology Hematology, P.A. — Minneapolis, Minnesota, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Women's Cancer Center of Nevada — Las Vegas, Nevada, United States (enrolling)
- Good Samaritan Hospital Medical Center — West Islip, New York, United States (enrolling)
- FirstHealth Carolinas — Pinehurst, North Carolina, United States (enrolling)
- OhioHealth Institute — Columbus, Ohio, United States (enrolling)
- Oklahoma Cancer Specialists and Research Institute — Tulsa, Oklahoma, United States (enrolling)
- Oncology Associates of Oregon — Eugene, Oregon, United States (enrolling)
- Northwest Cancer Specialists — Portland, Oregon, United States (enrolling)
- Texas Oncology-Austin Central — Austin, Texas, United States (enrolling)
- Texas Oncology-Fort Worth Cancer Center — Fort Worth, Texas, United States (enrolling)
- Texas Oncology-San Antonio Medical Center — San Antonio, Texas, United States (enrolling)
- University Hospital Graz, Department of Gynecology and Obstetrics — Graz, Austria (enrolling)
- Medizinische Universität Innsbruck — Innsbruck, Austria (enrolling)
- Medizinische Universität Wien — Vienna, Austria (enrolling)
- Cross Cancer Institute — Edmonton, Canada (enrolling)
- CHUM - University of Montreal Hospital Centre — Montreal, Canada (enrolling)
- Odense University Hospital — Odense, Denmark (enrolling)
- Kaiser Permanente Center — Vallejo, California, United States (enrolling)
Full record on ClinicalTrials.gov
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