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

Last updated: April 30, 2024
Sponsor: Kartos Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Endometrial Cancer

Endometriosis

Pelvic Cancer

Treatment

Navtemadlin Placebo

Navtemadlin

Clinical Study ID

NCT05797831
KRT-232-118
GOG-3089
ENGOT en-21
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ECOG 0-1
  • Histologically or cytologically confirmed diagnosis of endometrial cancer documentedas 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

Exclusion Criteria:

  • Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
  • Prior immune therapy, cytokine therapy, or any investigational therapy (within 28days)
  • Indwelling surgical drains
  • Grade 2 or higher QTc prolongation
  • History of major organ transplant
  • History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24weeks)

Study Design

Total Participants: 268
Treatment Group(s): 2
Primary Treatment: Navtemadlin Placebo
Phase: 2/3
Study Start date:
July 17, 2023
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • University Hospital Graz, Department of Gynecology and Obstetrics

    Graz, 8036
    Austria

    Active - Recruiting

  • Medizinische Universität Innsbruck

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Vienna, 1090
    Austria

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, T6G 1Z2
    Canada

    Active - Recruiting

  • CHUM - University of Montreal Hospital Centre

    Montreal, H2X 3E4
    Canada

    Active - Recruiting

  • Odense University Hospital

    Odense, DK-5000
    Denmark

    Active - Recruiting

  • Tartu University Hospital

    Tartu, 50406
    Estonia

    Active - Recruiting

  • Kuopio University Hospital

    Kuopio, 70200
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, 20520
    Finland

    Active - Recruiting

  • LTD High Technology hospital Medcenter

    Batumi, 6000
    Georgia

    Active - Recruiting

  • American Hospital Network LLC

    Tbilisi, 0102
    Georgia

    Active - Recruiting

  • Caucasus Medical Centre

    Tbilisi, 0186
    Georgia

    Active - Recruiting

  • National Institute of Oncology

    Budapest, H-1122
    Hungary

    Active - Recruiting

  • University of Debrecen Clinical Center

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • Rambam Medical Center

    Haifa, Rambam Medical Center
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel-Aviv, 6423906
    Israel

    Active - Recruiting

  • A.O. Cannizzaro

    Catania, 95126
    Italy

    Active - Recruiting

  • IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"

    Forli, 47014
    Italy

    Active - Recruiting

  • Ospedale Policlinico San Martino

    Genoa, 16132
    Italy

    Active - Recruiting

  • ASST di Lecco-Ospedale Alessandro Manzoni

    Lecco, 23900
    Italy

    Active - Recruiting

  • Ospedale San Luca

    Lucca, 55100
    Italy

    Active - Recruiting

  • Osp. Niguarda

    Milan, 20162
    Italy

    Active - Recruiting

  • University Hospital of Parma

    Parma, 43126
    Italy

    Active - Recruiting

  • Ospedale Guglielmo da Saliceto

    Piacenza, 29121
    Italy

    Active - Recruiting

  • Ospedale di Prato S. Stefano

    Prato, 59100
    Italy

    Active - Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121
    Italy

    Active - Recruiting

  • "Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"

    Rimini, 47923
    Italy

    Active - Recruiting

  • Policlinico Umberto

    Rome, 00161
    Italy

    Active - Recruiting

  • Ospedale Filippo Del Ponte

    Varese, 21110
    Italy

    Active - Recruiting

  • Health Sciences Kaunas Clinics

    Kaunas, LT-45434
    Lithuania

    Active - Recruiting

  • Nation Cancer Institute of Lithuania, Vilnius

    Vilnius, LT-08660
    Lithuania

    Active - Recruiting

  • Southern Hospital Sorlandet

    Kristiansand, 4604
    Norway

    Active - Recruiting

  • Oslo University Hospital HF

    Oslo, 0379
    Norway

    Active - Recruiting

  • Sykehusapotek Nord Tromsø

    Tromsø, 9038
    Norway

    Active - Recruiting

  • Białostockie Centrum Onkologii

    Bialystok, 15-027
    Poland

    Active - Recruiting

  • Szpitale Pomorskie

    Gdansk, 80-210
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, 80-214
    Poland

    Active - Recruiting

  • NIO-PIB Oddzial w Gliwicach

    Gliwice, 44-102
    Poland

    Active - Recruiting

  • Centrum Badań klinicznych Jagiellońskie Centrum Innowacji

    Kraków, 31-115
    Poland

    Active - Recruiting

  • Siedleckie Centrum Onkologii

    Olsztyn, 10-228
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital

    Poznan, 60-569
    Poland

    Active - Recruiting

  • NIO-PIB Klinika Gine-Onk

    Warsaw, 02-781
    Poland

    Active - Recruiting

  • Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology

    Wroclaw, 53-413
    Poland

    Active - Recruiting

  • Bucharest CF2 Hospital

    Bucharest, 012244
    Romania

    Active - Recruiting

  • Ovidius Clinical Hospital SRL

    Constanta, 905900
    Romania

    Active - Recruiting

  • Onco Clinic Consult S.A.

    Craiova, 200094
    Romania

    Active - Recruiting

  • Oncology Center "Sf. Nectarie"

    Craiova, 200542
    Romania

    Active - Recruiting

  • Gral Medical S.R.L. - Oncofort Hospital

    Piteşti, 110283
    Romania

    Active - Recruiting

  • Oncocenter, Oncology Clinic SRL

    Timisoara, 300166
    Romania

    Active - Recruiting

  • SC Oncomed SRL

    Timisoara, 300239
    Romania

    Active - Recruiting

  • Institute of Oncology Ljubljana

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

  • University Clinical Center Maribor

    Maribor, 2000
    Slovenia

    Active - Recruiting

  • CHUAC (Hospital de Coruña)

    A Coruna, 15006
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Galdakao-Usansolo

    Galdakao, 48960
    Spain

    Active - Recruiting

  • Hospital Universitario de Jaen

    Jaen, 23007
    Spain

    Active - Recruiting

  • H.G.U. Jerez de la Frontera

    Jerez de la Frontera, 11407
    Spain

    Active - Recruiting

  • Hospital U Insular de GC

    Las Palmas, 35016
    Spain

    Active - Recruiting

  • Hospital de Leon

    Leon, 24008
    Spain

    Active - Recruiting

  • HCU Santiago de Compostela

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Hospital Universitario de Valme

    Seville, 41014
    Spain

    Active - Recruiting

  • Linkoping University Hospital

    Linköping, 581 85
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm, SE-171 76
    Sweden

    Active - Recruiting

  • Kaiser Permanente Center

    Vallejo, California 94589
    United States

    Active - Recruiting

  • Northside Hospital

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • St. Joseph

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Dr. Sudarshan K. Sharma, Ltd.

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Parkview Research Center

    Fort Wayne, Indiana 46845
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Maryland Oncology Hematology, P.A.

    Silver Spring, Maryland 20904
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Good Samaritan Hospital Medical Center

    West Islip, New York 11795
    United States

    Active - Recruiting

  • FirstHealth Carolinas

    Pinehurst, North Carolina 28374
    United States

    Active - Recruiting

  • OhioHealth Institute

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

  • Oncology Associates of Oregon

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Northwest Cancer Specialists

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Texas Oncology-Austin Central

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Texas Oncology-San Antonio Medical Center

    San Antonio, Texas 78130
    United States

    Active - Recruiting

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