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Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
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.
Conditions:
🦠 Endometrial Cancer
πŸ—“οΈ Study Start (Actual) 17 July 2023
πŸ—“οΈ Primary Completion (Estimated) August 2025
βœ… Study Completion (Estimated) July 2027
πŸ‘₯ Enrollment (Estimated) 268
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase PHASE2
Locations:
πŸ“ Vallejo, California, United States
πŸ“ Atlanta, Georgia, United States
πŸ“ Savannah, Georgia, United States
πŸ“ Hinsdale, Illinois, United States
πŸ“ Fort Wayne, Indiana, United States
πŸ“ Indianapolis, Indiana, United States
πŸ“ Silver Spring, Maryland, United States
πŸ“ Minneapolis, Minnesota, United States
πŸ“ Saint Louis, Missouri, United States
πŸ“ Las Vegas, Nevada, United States
πŸ“ West Islip, New York, United States
πŸ“ Pinehurst, North Carolina, United States
πŸ“ Columbus, Ohio, United States
πŸ“ Tulsa, Oklahoma, United States
πŸ“ Eugene, Oregon, United States
πŸ“ Portland, Oregon, United States
πŸ“ Austin, Texas, United States
πŸ“ Fort Worth, Texas, United States
πŸ“ San Antonio, Texas, United States
πŸ“ Graz, Austria
πŸ“ Innsbruck, Austria
πŸ“ Vienna, Austria
πŸ“ Edmonton, Canada
πŸ“ Montreal, Canada
πŸ“ Odense, Denmark
πŸ“ Tartu, Estonia
πŸ“ Kuopio, Finland
πŸ“ Turku, Finland
πŸ“ Batumi, Georgia
πŸ“ Tbilisi, Georgia
πŸ“ Tbilisi, Georgia
πŸ“ Budapest, Hungary
πŸ“ Debrecen, Hungary
πŸ“ Haifa, Israel
πŸ“ Jerusalem, Israel
πŸ“ Tel-Aviv, Israel
πŸ“ Catania, Italy
πŸ“ Forli, Italy
πŸ“ Genoa, Italy
πŸ“ Lecco, Italy
πŸ“ Lucca, Italy
πŸ“ Milan, Italy
πŸ“ Parma, Italy
πŸ“ Piacenza, Italy
πŸ“ Prato, Italy
πŸ“ Ravenna, Italy
πŸ“ Rimini, Italy
πŸ“ Rome, Italy
πŸ“ Varese, Italy
πŸ“ Kaunas, Lithuania
πŸ“ Vilnius, Lithuania
πŸ“ Kristiansand, Norway
πŸ“ Oslo, Norway
πŸ“ TromsΓΈ, Norway
πŸ“ Bialystok, Poland
πŸ“ Gdansk, Poland
πŸ“ GdaΕ„sk, Poland
πŸ“ Gliwice, Poland
πŸ“ KrakΓ³w, Poland
πŸ“ Olsztyn, Poland
πŸ“ Poznan, Poland
πŸ“ Warsaw, Poland
πŸ“ Wroclaw, Poland
πŸ“ Bucharest, Romania
πŸ“ Constanta, Romania
πŸ“ Craiova, Romania
πŸ“ Craiova, Romania
πŸ“ Piteşti, Romania
πŸ“ Timisoara, Romania
πŸ“ Timisoara, Romania
πŸ“ Ljubljana, Slovenia
πŸ“ Maribor, Slovenia
πŸ“ A Coruna, Spain
πŸ“ Barcelona, Spain
πŸ“ Galdakao, Spain
πŸ“ Jaen, Spain
πŸ“ Jerez de la Frontera, Spain
πŸ“ Las Palmas, Spain
πŸ“ Leon, Spain
πŸ“ Santiago de Compostela, Spain
πŸ“ Seville, Spain
πŸ“ LinkΓΆping, Sweden
πŸ“ Stockholm, Sweden
More locations available...

πŸ“‹ Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 March 2023
  • First Submitted that Met QC Criteria 21 March 2023
  • First Posted 4 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 April 2024
  • Last Update Posted 2 May 2024
  • Last Verified April 2024
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