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)
NCT ID: NCT04113616
Last Updated: 2024-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2019-09-25
2023-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A - Arm 1
KRT-232+LDAC:
KRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with LDAC administered at 20 mg/m2/day subcutaneously on Days 1-10 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
Cytarabine
Cytarabine is an anti-cancer chemotherapy drug taken via injection.
Part A - Arm 2
KRT-232(7-Day)+Decitabine:
KRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
Decitabine
Decitabine is an anti-cancer chemotherapy drug taken via injection.
Part A - Arm 3
KRT-232(14-Day)+Decitabine:
KRT-232 will be administered orally, once daily (QD), on Days 1-7 and Days 15-21 (7 days on/7 days off/7 days on/7 days off) in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
Decitabine
Decitabine is an anti-cancer chemotherapy drug taken via injection.
Part B - Arm 1
KRT-232 administered at 360 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day treatment cycle
KRT-232
KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
Part B - Arm 2
KRT-232 administered at 360 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day treatment cycle in Cycle 1, followed by 240 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day cycle, in the subsequent cycles.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
Part B - Arm 3
KRT-232 administered at 180 mg orally, once daily (QD) on Days 1-7 with 14 days off on a 21-day treatment cycle.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
Interventions
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KRT-232
KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
Cytarabine
Cytarabine is an anti-cancer chemotherapy drug taken via injection.
Decitabine
Decitabine is an anti-cancer chemotherapy drug taken via injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part B:Patients with relapsed or refractory AML secondary to MPN (myelofibrosis \[MF\], polycythemia vera \[PV\], or essential thrombocythemia \[ET\]); patients may have been treated with ≥1 prior lines of therapy for their AML secondary to MPN.
* Adequate hepatic and renal function
* Appropriate prior treatment with an FLT3 or IDH1/2 inhibitor where applicable
Exclusion Criteria
* Prior treatment with an MDM2 antagonist therapy
* Patients treated with ≥ 18 g/m2 of cytarabine within the prior 90 days are not eligible to be treated with cytarabine on this study but may be treated with decitabine (for Part A) .
* Patients previously treated with decitabine are not eligible to receive decitabine on this study but may be treated with cytarabine (for Part A) .
* Patients who have received an allogeneic HSCT within 90 days of enrollment or who have active graft-versus-host disease requiring active therapy (for Part A)
* Allogeneic stem cell transplant within 3 months; autologous stem cell transplant within 3 months or active graft-versus-host disease prior to first dose of study treatment (for Part B)
* Patients who have received immunosuppressive therapy for graft-versus-host disease within 1 month prior to enrollment into this study
* Patients who are eligible for an allogeneic HSCT per the opinion of the investigator and have a donor. Patients who are HSCT-eligible in the opinion of the investigator, but who refuse a transplant, are eligible for the study.
* Patients with known CNS involvement with AML, acute promyelocytic leukemia (APL), or a history of bleeding diathesis
* Patients who have had major surgery within 28 days prior to the first treatment with KRT-232
* Women who are pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Kartos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
University of Chicago
Chicago, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
Monash Health
Clayton, , Australia
St. George Hospital
Kogarah, , Australia
Royal Perth Hospital
Perth, , Australia
Calvary Mater Newcastle Hospital
Waratah, , Australia
Perth Blood Institute
West Perth, , Australia
Institut Jules Bordet
Anderlecht, , Belgium
Cliniques universitaires Saint-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Centre Hospitalier (CH) Jolimont
Haine-Saint-Paul, , Belgium
AZ Turnhout
Turnhout, , Belgium
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, , France
Institut Paoli Calmettes
Marseille, , France
Centre Hospitalier Universitaire (CHU) de Nice
Nice, , France
Hôpital Saint-Louis
Paris, , France
Universitätsklinikum Halle
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
University Hospital Jena
Jena, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologi
Budapest, , Hungary
szabolcs-szatmár-bereg megyei kórházak és egyetemi oktatókórház Jósa András Oktatókórház
Debrecen, , Hungary
Somogy Megyei KAposi Mor Oktato Korhaz
Kaposvár, , Hungary
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Center Ein Kerem
Jerusalem, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Assaf Harofeh Medical Center AHMC
Tel Aviv, , Israel
Universitaria Maggiore della Carità Novara
Novara, Piedmont, Italy
A.O.O.R. Villa Sofia Cervello
Palermo, Sicily, Italy
AOU Policlinico S.Orsola-Malpighi
Bologna, , Italy
AORMN Hospital Hematology and BMT Center
Pesaro, , Italy
AOUS Le Scotte
Siena, , Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Inje University Busan Paik Hospital
Busan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea-Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Victoria de Málaga
Málaga, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Oxford University Hospitals NHS Trust, Churchill Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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KRT-232-104
Identifier Type: -
Identifier Source: org_study_id
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