Myeloproliferative Neoplasms Clinical Trial

KRT-232 and TKI Study in Chronic Myeloid Leukemia

Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ leukemia-cml/" >Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP
Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP
Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI.
Adults ≥ 18 years of age.
ECOG performance status of 0 to 2
Adequate hematologic, hepatic, and renal functions

Exclusion Criteria:

Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP
Documented Ph+, BCR-ABL+ CML-BC
Known T315I mutation.
Prior treatment with MDM2 antagonist therapies.
Intolerance to current TKI therapy.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

109

Study ID:

NCT04835584

Recruitment Status:

Recruiting

Sponsor:

Kartos Therapeutics, Inc.

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There are 23 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35294, United States
Georgia Cancer Center at Augusta University
Augusta Georgia, 30912, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Texas Oncology- Sammons CC at Baylor
Dallas Texas, 75246, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
Centre Leon Berard
Lyon , 69008, France
APHM Hopital de la Timone
Marseille , 13005, France
Institut Paoli-Calmettes
Marseille , 13009, France
Centre Hospitalier Lyon Sud
Saint-Genis-Laval , 69310, France
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
Milano MI, 20122, Italy
Azienda Ospedaliero - Universitaria Mater Domini
Catanzaro , 88100, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola FC , 47014, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Kyungpook National University Hospital
Daegu , , Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Severance Hospital
Seoul , , Korea, Republic of
Pratia Onkologia Katowice
Katowice , 40-51, Poland
National Medical Research Center of Hematology
Moscow , 12516, Russian Federation
Almazov National Medical Research Center
Saint Petersburg , 19734, Russian Federation
Samara State Medical University
Samara , 44300, Russian Federation
Clínica Universidad de Navarra
Madrid Navarra, 28027, Spain
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

109

Study ID:

NCT04835584

Recruitment Status:

Recruiting

Sponsor:


Kartos Therapeutics, Inc.

How clear is this clinincal trial information?

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