Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Part of paid clinical trials in Vallejo, California.

Sponsor
Kartos Therapeutics, Inc.
Study ID
NCT05797831
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Navtemadlin — DRUG
    Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
  • Navtemadlin Placebo — DRUG
    Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Study Details

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 Dates

Start date
Jul 17, 2023
Status verified
Apr 2024
Primary completion
Aug 31, 2025
Completion
Jul 31, 2027

Study Design

Enrollment
268 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Arm 1
    Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Experimental: Part 1 Arm 2
    Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • No Intervention: Part 1 Arm 3
    Observational control ("watch and wait") on a 28-day cycle.
  • Experimental: Part 2 Arm A
    Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Experimental: Part 2 Arm B
    Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Placebo Comparator: Part 2 Arm C
    Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
  • Placebo Comparator: Part 2 Arm D
    Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.

Primary Outcome Measure

Part 1: To determine the navtemadlin Phase 3 dose [ Time Frame: 12 months ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Kaiser Permanente CenterVallejoCalifornia94589-
Northside HospitalAtlantaGeorgia30342-
St. JosephSavannahGeorgia31405-
Dr. Sudarshan K. Sharma, Ltd.HinsdaleIllinois60521-
Parkview Research CenterFort WayneIndiana46845-
Indiana UniversityIndianapolisIndiana46202-
Maryland Oncology Hematology, P.A.Silver SpringMaryland20904-
Minnesota Oncology Hematology, P.A.MinneapolisMinnesota55404-
Washington University School of MedicineSt LouisMissouri63108-
Women's Cancer Center of NevadaLas VegasNevada89106-
Good Samaritan Hospital Medical CenterWest IslipNew York11795-
FirstHealth CarolinasPinehurstNorth Carolina28374-
OhioHealth InstituteColumbusOhio43214-
Oklahoma Cancer Specialists and Research InstituteTulsaOklahoma74146-
Oncology Associates of OregonEugeneOregon97401-
Northwest Cancer SpecialistsPortlandOregon97227-
Texas Oncology-Austin CentralAustinTexas78745-
Texas Oncology-Fort Worth Cancer CenterFort WorthTexas76104-
Texas Oncology-San Antonio Medical CenterSan AntonioTexas78130-

Find similar trials in Vallejo, CA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Kaiser Permanente Center· Vallejo, CANorthside Hospital· Atlanta, GASt. Joseph· Savannah, GADr. Sudarshan K. Sharma, Ltd.· Hinsdale, ILParkview Research Center· Fort Wayne, INIndiana University· Indianapolis, IN

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