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Search / Trial NCT03662126

KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment

Launched by KARTOS THERAPEUTICS, INC. · Sep 5, 2018

Trial Information

Current as of November 01, 2025

Recruiting

Keywords

Navtemadlin

ClinConnect Summary

This clinical trial is studying a new treatment called KRT-232 for patients with myelofibrosis (MF), a type of blood cancer, who have not responded to previous treatments with JAK inhibitors. KRT-232 is an oral medication that works differently than existing therapies by blocking a specific protein involved in cancer cell growth. The trial has two phases: the first phase will find the best dose of KRT-232, and the second phase will compare KRT-232 to the best available therapy, which will be chosen by the patient's doctor. Participants will be randomly assigned to receive either KRT-232 or the best available therapy, with the option to switch to KRT-232 if their condition worsens.

To be eligible for the trial, participants must have been diagnosed with certain types of myelofibrosis and have not benefited from JAK inhibitor treatment. They should also have a score indicating their disease risk and be in relatively good health (ECOG score of 2 or lower). However, people with certain medical histories, such as recent major bleeding or previous organ transplants, cannot participate. If you decide to join the study, you will receive regular check-ups and monitoring to assess your response to the treatment. This trial is currently recruiting patients aged 65 and older, and it welcomes both men and women.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  • High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
  • Failure of prior treatment with JAK inhibitor
  • ECOG ≤ 2
  • Exclusion Criteria:
  • Prior splenectomy
  • Splenic irradiation within 3 months prior to randomization
  • History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
  • History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
  • Prior MDM2 inhibitor therapy or p53-directed therapy
  • Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
  • History of major organ transplant
  • Grade 2 or higher QTc prolongation (\> 480 milliseconds per NCI-CTCAE criteria, version 5.0)

About Kartos Therapeutics, Inc.

Kartos Therapeutics, Inc. is a biopharmaceutical company dedicated to the advancement of innovative therapies for patients with cancer and other serious diseases. Focused on developing targeted treatments that address unmet medical needs, Kartos utilizes cutting-edge research and technology to enhance patient outcomes. The company is committed to rigorous clinical development processes, ensuring the safety and efficacy of its therapeutic candidates. With a team of experienced professionals, Kartos Therapeutics aims to transform the landscape of oncology treatment through scientific excellence and a patient-centered approach.

Locations

Saint Louis, Missouri, United States

Sioux Falls, South Dakota, United States

Chicago, Illinois, United States

Brooklyn, New York, United States

Bangkok, Thailand

Boston, Massachusetts, United States

Seoul, Korea, Republic Of

Nashville, Tennessee, United States

Adelaide, Australia

Portland, Oregon, United States

Chicago, Illinois, United States

Canton, Ohio, United States

Salamanca, Spain

Clayton, Victoria, Australia

Buenos Aires, Argentina

Houston, Texas, United States

Barcelona, Spain

Jerusalem, Israel

Taichung, Taiwan

Seoul, Korea, Republic Of

Paris, France

Badalona, Barcelona, Spain

Poitiers, France

Melbourne, Australia

Seoul, Korea, Republic Of

Seoul, Korea, Republic Of

Haifa, Israel

Nashville, Tennessee, United States

Bucharest, Romania

Málaga, Spain

Hong Kong, Hong Kong

Roma, Italy

Dresden, Sachsen, Germany

Lublin, Poland

Berlin, Germany

Ankara, Turkey

Barcelona, Spain

Aachen, Nordrhein Westfalen, Germany

Budapest, Hungary

Brescia, Italy

Boynton Beach, Florida, United States

Milano, Italy

Cluj Napoca, Romania

Songkhla, Thailand

Birmingham, United Kingdom

Whittier, California, United States

Columbus, Ohio, United States

Los Angeles, California, United States

Daegu, Korea, Republic Of

Mutlangen, Germany

Glasgow, United Kingdom

New York, New York, United States

Taipei City, Taipei, Taiwan

Busan, Korea, Republic Of

Nahariya, Israel

Halle, Sachsen Anhalt, Germany

Valencia, Spain

Milwaukee, Wisconsin, United States

Sibenik, Croatia

Kaposvár, Somogy, Hungary

Braga, Portugal

Malatya, Turkey

Toronto, Ontario, Canada

Daegu, Korea, Republic Of

Bucuresti, Romania

Daegu, Korea, Republic Of

Majadahonda, Madrid, Spain

Novara, Italy

Palma De Mallorca, Spain

Milano, Italy

Essen, Nordrhein Westfalen, Germany

Seoul, Korea, Republic Of

Toulouse, France

London, United Kingdom

Craiova, Romania

Ioánnina, Ioannina, Greece

Haifa, Israel

Afula, Israel

Szeged, Hungary

Saarbrücken, Germany

Le Mans, France

Iaşi, Romania

Chorzów, Slaskie, Poland

Opole, Poland

Las Palmas De Gran Canaria, Las Palmas, Spain

Oxford, Oxfordshire, United Kingdom

Olomouc, Czechia

New York, New York, United States

Jena, Thuringen, Germany

Brest Cedex, France

Birmingham, Alabama, United States

Stanford, California, United States

Rosario, Santa Fe, Argentina

Caba, Argentina

Noble Park, Australia

South Brisbane, Australia

Curitiba, Parana, Brazil

Campinas, São Paulo, Brazil

Goiânia, Brazil

Jau, Brazil

Porto Alegre, Brazil

Porto Alegre, Brazil

Sao Paulo, Brazil

Sao Paulo, Brazil

São Paulo, Brazil

São Paulo, Brazil

Pleven, Bulgaria

Plovdiv, Bulgaria

Sofia, Bulgaria

Sofia, Bulgaria

Sofia, Bulgaria

Sofia, Bulgaria

Zagreb, Croatia

Králová, Czechia

Nové Město, Czechia

Amiens, France

Angers, France

Bayonne, France

Caen, France

Nîmes, France

Villejuif, France

München, Bayern, Germany

Dresden, Sachsen, Germany

Hamburg, Germany

Mainz, Germany

Nyíregyháza, Szabolcs Szatmar Bereg, Hungary

Szombathely, Vas, Hungary

Budapest, Hungary

Debrecen, Hungary

Ashdod, Israel

Kfar Saba, Israel

Petah Tikva, Israel

Tel Aviv, Israel

Tel Aviv, Israel

Zerifin, Israel

Alessandria, Italy

Ancona, Italy

Bologna, Italy

Catania, Italy

Firenze, Italy

Meldola, Italy

Pesaro, Italy

Reggio Emilia, Italy

Seongnam Si, Korea, Republic Of

Kaunas, Lithuania

Monterrey, Mexico

Veracruz, Mexico

Cebu City, Philippines

Manila, Philippines

Wrocław, Dolnoslaskie, Poland

Brzozow, Podkarpackie, Poland

Olsztyn, Poland

Poznań, Poland

Słupsk, Poland

Aveiro, Portugal

Lisboa, Portugal

Lisbon, Portugal

Omsk, Russian Federation

St Petersburg, Russian Federation

Syktyvkar, Russian Federation

Pamplona, Spain

Zaragoza, Spain

Bangkok, Thailand

Khlong Luang, Thailand

Khon Kaen, Thailand

Adapazarı, Turkey

Ankara, Turkey

Gaziantep, Turkey

Mersin, Turkey

Coimbra, Portugal

Kaohsiung, Taiwan

Denizli, Turkey

Córdoba, Argentina

Fortaleza, Ceara, Brazil

Sao Paulo, Brazil

Zagreb, Croatia

Shatin, Hong Kong

Torino, Italy

Monterrey, Nuevo Leon, Mexico

Bydgoszcz, Poland

Brasov, Romania

Bucuresti, Romania

Timişoara, Romania

Timişoara, Romania

Târgu Mureş, Romania

Cáceres, Spain

Chiayi City, Taiwan

Monza, Lombardia, Italy

Murdoch, Western Australia, Australia

Sofia, Bulgaria

Patras, Greece

Thessaloníki, Greece

Oaxaca, Mexico

Samsun, Turkey

Campinas, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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