Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
- Conditions
- Endometrial Cancer
- Interventions
- Registration Number
- NCT05797831
- Lead Sponsor
- Kartos Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 268
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2 Arm D Navtemadlin Placebo Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle. Part 2 Arm C Navtemadlin Placebo Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle. Part 2 Arm A Navtemadlin Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles. Part 1 Arm 2 Navtemadlin Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles. Part 1 Arm 1 Navtemadlin Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles. Part 2 Arm B Navtemadlin Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
- Primary Outcome Measures
Name Time Method Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo 50 months PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first
Part 1: To determine the navtemadlin Phase 3 dose 12 months Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
- Secondary Outcome Measures
Name Time Method Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST) 50 months TFST defined as the time from randomization to initiation of first subsequent anticancer therapy or death, whichever occurs first
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin 1 day Will determine the time of maximum plasma concentration (Tmax)
Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR) 50 months Best response of complete response (CR), partial response (PR) or stable disease (SD) by IRC/investigator assessment among subjects with PR as best response from prior chemotherapy
Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment 50 months PFS defined as the time from randomization to disease progression by IRC/investigator assessment or death, whichever occurs first
Related Research Topics
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Trial Locations
- Locations (83)
Kaiser Permanente Center
🇺🇸Vallejo, California, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
St. Joseph
🇺🇸Savannah, Georgia, United States
Dr. Sudarshan K. Sharma, Ltd.
🇺🇸Hinsdale, Illinois, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Maryland Oncology Hematology, P.A.
🇺🇸Silver Spring, Maryland, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Scroll for more (73 remaining)Kaiser Permanente Center🇺🇸Vallejo, California, United States