Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05797831 | RECRUITING | Endometrial Cancer

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

Condition or disease

Endometrial Cancer

Intervention/treatment

Navtemadlin

Navtemadlin Placebo

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 268 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
Actual Study Start Date : 2023-07-17
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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)
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Location Details

NCT05797831

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Kaiser Permanente Center

Vallejo, California, United States, 94589

RECRUITING

United States, Georgia

Northside Hospital

Atlanta, Georgia, United States, 30342

RECRUITING

United States, Georgia

St. Joseph

Savannah, Georgia, United States, 31405

RECRUITING

United States, Illinois

Dr. Sudarshan A. Sharma, Ltd.

Hinsdale, Illinois, United States, 60521

RECRUITING

United States, Indiana

Parkview Research Center

Fort Wayne, Indiana, United States, 46845

RECRUITING

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Maryland

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, United States, 20904

RECRUITING

United States, Minnesota

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States, 55404

RECRUITING

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63108

RECRUITING

United States, Nevada

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States, 89106

RECRUITING

United States, New York

Good Samaritan Hospital Medical Center

West Islip, New York, United States, 11795

RECRUITING

United States, North Carolina

FirstHealth Carolinas

Pinehurst, North Carolina, United States, 28374

RECRUITING

United States, Ohio

OhioHealth Institute

Columbus, Ohio, United States, 43214

RECRUITING

United States, Oklahola

Oklahoma Cancer Specialists and Research Institute

Tulsa, Okholohan, United States, 74146

RECRUITING

United States, Oregon

Oncology Associates of Oregon

Eugene, Oregon, United States, 97401

RECRUITING

United States, Oregon

Northwest Cancer Specialists

Portland, Oregon, United States, 97227

RECRUITING

United States, Texas

Texas Oncology-Austin Central

Austin, Texas, United States, 78745

RECRUITING

United States, Texas

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, United States, 76104

RECRUITING

United States, Texas

Texas Oncology-San Antonio Medical Center

San Antonio, Texas, United States, 78130

RECRUITING

Austria,

University Hospital Graz, Department of Gynecology and Obstetrics

Graz, Austria, 8036

RECRUITING

Austria,

Medical University of Innsbruck

Innsbruck, Austria, 6020

RECRUITING

Austria,

Medical University of Vienna

Vienna, Austria, 1090

RECRUITING

Canada,

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

RECRUITING

Canada,

CHUM - University of Montreal Hospital Centre

Montreal, Canada, H2X 3E4

RECRUITING

Denmark,

Odense University Hospital

Odense, Denmark, DK-5000

RECRUITING

Estonia,

Tartu University Hospital

Tartu, Estonia, 50406

RECRUITING

Finland,

Kuopio University Hospital

Kuopio, Finland, 70200

RECRUITING

Finland,

Turku University Hospital

Turku, Finland, 20520

RECRUITING

Georgia,

LTD High Technology hospital Medcenter

Batumi, Georgia, 6000

RECRUITING

Georgia,

American Hospital Network LLC

Tbilisi, Georgia, 0102

RECRUITING

Georgia,

Caucasus Medical Centre

Tbilisi, Georgia, 0186

RECRUITING

Hungary,

National Institute of Oncology

Budapest, Hungary, H-1122

RECRUITING

Hungary,

University of Debrecen Clinical Center

Debrecen, Hungary, 4032

RECRUITING

Israel,

Rambam Medical Center

Haifa, Israel, Rambam Medical Center

RECRUITING

Israel,

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

RECRUITING

Israel,

Sourasky Medical Center

Tel-Aviv, Israel, 6423906

RECRUITING

Italy,

A.O. Canal

Catania, Italy, 95126

RECRUITING

Italy,

IRCCS Romagna Institute for the Study of "Dino Amadori" tumors

Forli, Italy, 47014

RECRUITING

Italy,

San Martino Policlinico Hospital

Genoa, Italy, 16132

RECRUITING

Italy,

ASST of Lecco-hospital Alessandro Manzoni

Lecco, Italy, 23900

RECRUITING

Italy,

San Luca Hospital

Lucca, Italy, 55100

RECRUITING

Italy,

OSP. Nigueard

Milan, Italy, 20162

RECRUITING

Italy,

University Hospital of Parma

Parma, Italy, 43126

RECRUITING

Italy,

Guglielmo da Saliceto Hospital

Piacenza, Italy, 29121

RECRUITING

Italy,

Hospital of Prato S. Stefano

Prato, Italy, 59100

RECRUITING

Italy,

Santa Maria delle Croci Hospital

Ravenna, Italy, 48121

RECRUITING

Italy,

"Local health unit of Romagna - Hospital" "Infirm" "of Rimini Oncology Department"

Rimini, Italy, 47923

RECRUITING

Italy,

Umberto Polyclinic

Rome, Italy, 00161

RECRUITING

Italy,

Filippo del Ponte Hospital

Varese, Italy, 21110

RECRUITING

Lithuania,

Health Sciences Kaunas Clinics

Kaunas, Lithuania, LT-45434

RECRUITING

Lithuania,

Nation Cancer Institute of Lithuania, Vilnius

Vilnius, Lithuania, LT-08660

RECRUITING

Norway,

Southern Hospital Sorlandet

Kristiansand, Norway, 4604

RECRUITING

Norway,

Oslo University Hospital HF

Oslo, Norway, 0379

RECRUITING

Norway,

Hospital Pharmacy Nord Tromsø

Tromsø, Norway, 9038

RECRUITING

Poland,

Białystok Oncology Center

Bialystok, Poland, 15-027

RECRUITING

Poland,

Pomeranian hospitals

Gdansk, Poland, 80-210

RECRUITING

Poland,

University Clinical Center

Gdańsk, Poland, 80-214

RECRUITING

Poland,

NIO-PIB Breaky in Gliwice

Gliwice, Poland, 44-102

RECRUITING

Poland,

Clinical Research Center Jagiellonian Innovation Center

Cracow, Poland, 31-115

RECRUITING

Poland,

Siedlce Oncology Center

Olsztyn, Poland, 10-228

RECRUITING

Poland,

University hospital

Poznan, Poland, 60-569

RECRUITING

Poland,

NIO-Gen Clinic Guinea-Onk

Warsaw, Poland, 02-781

RECRUITING

Poland,

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

Wroclaw, Poland, 53-413

RECRUITING

Romania,

Bucharest CF2 Hospital

Bucharest, Romania, 012244

RECRUITING

Romania,

Ovid Clinical Hospital Srl

Constant, Romania, 905900

RECRUITING

Romania,

Onco Clinic Consult S.A.

Craiova, Romania, 200094

RECRUITING

Romania,

Oncology Center "Sf. Nectarie"

Craiova, Romania, 200542

RECRUITING

Romania,

Gral Medical S.R.L. - Oncofort Hospital

Pitesti, Romania, 110283

RECRUITING

Romania,

Oncocenter, Oncology Clinic SRL

Timisoara, Romania, 300166

RECRUITING

Romania,

SC Oncomed SRL

Timisoara, Romania, 300239

RECRUITING

Slovenia,

Institute of Oncology Ljubljana

Ljubljana, Slovenia, 1000

RECRUITING

Slovenia,

University Clinical Center Maribor

Maribor, Slovenia, 2000

RECRUITING

Spain,

Chuac (Coruña Hospital)

The corou, Spain, 15006

RECRUITING

Spain,

Hospital del Mar

Barcelona, Spain, 08003

RECRUITING

Spain,

Hospital Galdakao-Usansolo

Galdakao, Spain, 48960

RECRUITING

Spain,

Jaen University Hospital

Jaen, Spain, 23007

RECRUITING

Spain,

H.G.U. Jerez de la Frontera

Jerez de la Frontera, Spain, 11407

RECRUITING

Spain,

GC INSULAR HOSPITAL

Las Palmas, Spain, 35016

RECRUITING

Spain,

Leon Hospital

Leon, Spain, 24008

RECRUITING

Spain,

HCU Santiago of Compostela

Santiago de Compostela, Spain, 15706

RECRUITING

Spain,

Valme University Hospital

Seville, Spain, 41014

RECRUITING

Sweden,

Linkoping University Hospital

Linköping, Sweden, 581 85

RECRUITING

Sweden,

Karolinska University Hospital

Stockholm, Sweden, SE-171 76