NCT04113616 - An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 25, 2019

Primary Completion Date

September 27, 2023

Study Completion Date

September 27, 2023

Conditions

Relapsed or Refractory Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)

Interventions

DRUG

KRT-232

KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.

DRUG

Cytarabine

Cytarabine is an anti-cancer chemotherapy drug taken via injection.

DRUG

Decitabine

Decitabine is an anti-cancer chemotherapy drug taken via injection.

Trial Locations (59)

1070

Institut Jules Bordet, Anderlecht

1085

Semmelweis Egyetem, Budapest

2298

Calvary Mater Newcastle Hospital, Waratah

6000

Royal Perth Hospital, Perth

6005

Perth Blood Institute, West Perth

7100

Centre Hospitalier (CH) Jolimont, Haine-Saint-Paul

7400

Somogy Megyei KAposi Mor Oktato Korhaz, Kaposvár

10029

Mount Sinai, New York

10065

Memorial Sloan Kettering Cancer Center, New York

Weill Cornell, New York

13009

Institut Paoli Calmettes, Marseille

21201

University of Maryland Medical Center, Baltimore

28033

MD Anderson Cancer Center, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28100

Universitaria Maggiore della Carità Novara, Novara

29010

Hospital Universitario Virgen de la Victoria de Málaga, Málaga

33000

Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux

35010

Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas

37007

Hospital Universitario de Salamanca, Salamanca

43210

The Ohio State University, Columbus

46010

Hospital Clínico Universitario de Valencia, Valencia

53100

AOUS Le Scotte, Siena

60637

University of Chicago, Chicago

77030

MD Anderson Cancer Center, Houston

90146

A.O.O.R. Villa Sofia Cervello, Palermo

97239

Oregon Health and Science University, Portland

3109601

Rambam Health Care Campus, Haifa

5265601

The Chaim Sheba Medical Center, Ramat Gan

6423906

Tel-Aviv Sourasky Medical Center, Tel Aviv

Unknown

Monash Health, Clayton

St. George Hospital, Kogarah

Cliniques universitaires Saint-Luc, Brussels

UZ Gent, Ghent

AZ Turnhout, Turnhout

Hôpital Saint-Louis, Paris

Universitätsklinikum Halle, Halle

Universitätsklinikum Hamburg-Eppendorf, Hamburg

Universitätsklinikum Leipzig, Leipzig

Universitaetsklinikum Schleswig-Holstein, Lübeck

Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologi, Budapest

szabolcs-szatmár-bereg megyei kórházak és egyetemi oktatókórház Jósa András Oktatókórház, Debrecen

Hadassah Medical Center Ein Kerem, Jerusalem

Assaf Harofeh Medical Center AHMC, Tel Aviv

AOU Policlinico S.Orsola-Malpighi, Bologna

AORMN Hospital Hematology and BMT Center, Pesaro

Uniwersyteckie Centrum Kliniczne, Gdansk

Inje University Busan Paik Hospital, Busan

Samsung Medical Center, Seoul

The Catholic University of Korea-Seoul St. Mary's Hospital, Seoul

Hospital Universitario 12 de Octubre, Madrid

Birmingham Heartlands Hospital, Birmingham

University Hospital of Wales, Cardiff

Oxford University Hospitals NHS Trust, Churchill Hospital, Oxford

06000

Centre Hospitalier Universitaire (CHU) de Nice, Nice

07747

University Hospital Jena, Jena

03080

Seoul National University Hospital, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08035

Hospital Universitari Vall d'Hebron, Barcelona

SW3 6JJ

The Royal Marsden Hospital, London