Status:
TERMINATED
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)
Lead Sponsor:
Kartos Therapeutics, Inc.
Conditions:
Relapsed or Refractory Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with A...
Eligibility Criteria
Inclusion
- Key
- Part A: Patients with relapsed or refractory AML, or newly-diagnosed AML secondary to MPN
- 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
- Key
Exclusion
- Patients who are TP53 mutation positive
- 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
Key Trial Info
Start Date :
September 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04113616
Start Date
September 25 2019
End Date
September 27 2023
Last Update
March 22 2024
Active Locations (59)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
Mount Sinai
New York, New York, United States, 10029
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065