EUCTR2019-001545-41-DEActive, not recruitingPhase 1
A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Kura Oncology, Inc.
- Enrollment
- 236
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Key Inclusion Criteria:
- •1. Relapsed/refractory (R/R) acute myeloid leukemia (AML) defined as those who have also failed or are not appropriate for any approved standard-of-care (SOC) therapies or hematopoietic stem cell transplant (HSCT)with reappearance of = 5% blasts in the bone marrow (BM).
- •2. = 18 years of age.
- •3. Eastern Cooperative Oncology Group performance status of = 2, and a life expectancy of at least 2 months.
- •4. Peripheral white blood cell counts = 30,000/µL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 118
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 118
Exclusion Criteria
- •Key Exclusion Criteria
- •1. Diagnosis of acute promyelocytic leukemia or chronic myelogenous leukemia in blast crisis.
- •2. Donor lymphocyte infusion < 30 days prior to study entry.
- •3. Clinically active central nervous system (CNS) leukemia.
- •4. Has undergone HSCT and have not had adequate hematologic recovery (Recovery is defined as peripheral absolute neutrophil count (ANC) = 1 × 10^9/L and platelets at least = 50 × 10^9/L [but preferably = 100 × 109/L] and signs of a cellular BM).
- •5. Patients on immunosuppressive therapy post HSCT must be off all immunosuppression therapy within 2 weeks of Cycle 1 Day 1.
- •6. = Grade 2 active GvHD, moderate or severe limited chronic GvHD, or extensive chronic GvHD of any severity.
- •7. Has received prior menin inhibitor
- •8. Has received chemotherapy, immunotherapy, radiotherapy (unless if given for management of CNS leukemia), or any ancillary therapy that is considered to be investigational (ie, used for non-approved indications(s) and in the context of a research investigation) < 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug, whichever is shorter, to ensure that patient time without necessary AML therapy is appropriately limited.
- •9. Requires treatment with concomitant drugs that are strong inhibitors or inducers of CYP3A4 with the exception of antibiotics, antifungals, and antivirals that are used as SOC to prevent or treat infections. Other such drugs that are considered absolutely essential by the Investigator for the care of the patient should be discussed on a case-by-case basis with the Kura Medical Monitor.
- •10. Has an active uncontrolled acute or chronic systemic fungal, bacterial, viral, or other infection.
- •11. Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, history of cerebrovascular accident including transient ischemic attack within the past 6 months, congestive heart failure (New York Heart Association Class III or IV) related to primary cardiac disease, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the first dose of study treatment.
- •12. Mean corrected QT interval by Fredericia's formula > 480 ms on triplicate electrocardiograms.
Investigators
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