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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 23 Locations for this study
Birmingham Alabama, 35294, United States
Augusta Georgia, 30912, United States
Pittsburgh Pennsylvania, 15232, United States
Dallas Texas, 75246, United States
Milwaukee Wisconsin, 53226, United States
Toronto Ontario, M5G 2, Canada
Lyon , 69008, France
Marseille , 13005, France
Marseille , 13009, France
Saint-Genis-Laval , 69310, France
Milano MI, 20122, Italy
Catanzaro , 88100, Italy
Meldola FC , 47014, Italy
Pavia , 27100, Italy
Daegu , , Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Katowice , 40-51, Poland
Moscow , 12516, Russian Federation
Saint Petersburg , 19734, Russian Federation
Samara , 44300, Russian Federation
Madrid Navarra, 28027, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Madrid , 28046, Spain
How clear is this clinincal trial information?