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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06001788
Other study ID # KO-MEN-008
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 22, 2024
Est. completion date August 2027

Study information

Verified date May 2024
Source Kura Oncology, Inc.
Contact Clinical Operations
Phone 858 500 8800
Email KO-MEN-008@kuraoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.


Recruitment information / eligibility

Status Recruiting
Enrollment 171
Est. completion date August 2027
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Has been diagnosed with relapsed/refractory AML. - Has a documented NPM1 mutation or KMT2A rearrangement. - Has a documented FLT3 mutation (cohort A-3 only). - Has an Eastern Cooperative Oncology Group (ECOG) Performance status = 2. - Has adequate hepatic and renal function as defined per protocol. - Has an ejection fraction above a protocol defined limit. - Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure. - Has agreed to use contraception as defined per protocol. Key Exclusion Criteria: - Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia. - Has clinically active central nervous system leukemia. - Has an active and uncontrolled infection. - Has a mean corrected QT interval (QTcF) > 480ms. - Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. - Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy <14 days or within 5 drug half-lives prior to the first dose of study intervention. - Has had major surgery within 4 weeks prior to the first dose of study intervention. - Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria. - Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD. - Participant is pregnant or lactating.

Study Design


Intervention

Drug:
Ziftomenib
Oral administration
Fludarabine
Intravenous infusion
Idarubicin
Intravenous infusion
Cytarabine
Intravenous Infusion
Gilteritinib
Oral administration
Biological:
Granulocyte colony-stimulating factor
Subcutaneous injection

Locations

Country Name City State
United States Henry Ford Cancer Institute Detroit Michigan
United States Karmanos Cancer Institute Detroit Michigan
United States Prisma Health Greenville South Carolina
United States MD Anderson Cancer Center Houston Texas
United States The University of Kansas Kansas City Kansas
United States Smilow Cancer Hospital at Yale New Haven New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States OU Health Stephenson Cancer Center Oklahoma City Oklahoma
United States UCI Health Chao Family Comprehensive Cancer Center Orange California

Sponsors (1)

Lead Sponsor Collaborator
Kura Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of dose limiting toxicities (DLTs) per dose level Assessed by the NCI-CTCAE v5.0 During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)
Primary Descriptive statistics of adverse events Assessed by the NCI-CTCAE v5.0 First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the patient is lost to follow-up, whichever comes first
Secondary Complete remission (CR) rate for cohorts A-1, A-2, B-1, and B-2 Assessed by ELN 2022 criteria Up to 12 months following discontinuation of treatment
Secondary Complete remission (CR) / Complete remission with partial hematologic recovery (CRh) rate for cohort A-3 Assessed by ELN 2022 criteria Up to 12 months following discontinuation of treatment
Secondary Composite complete remission (CRc) rate Assessed by ELN 2022 criteria Up to 12 months following discontinuation of treatment
Secondary Morphologic leukemia-free state (MLFS) rate Assessed by ELN 2022 criteria Up to 12 months following discontinuation of treatment
Secondary OS To assess overall survival Up to 12 months following discontinuation of treatment
Secondary 6-month OS To assess proportion of patients alive at 6 months Up to 6 months following discontinuation of treatment
Secondary Median EFS To assess median event free survival Up to 12 months following discontinuation of treatment
Secondary 6-month EFS To assess 6-month event free survival Up to 6 months following discontinuation of treatment
Secondary DOR To assess duration of remission Up to 12 months following discontinuation of treatment
Secondary MRD assessment To assess minimum residual disease in bone marrow as assessed by multiparameter flow cytometry (MFC) and molecular analysis Up to 12 months following discontinuation of treatment
Secondary HSCT To assess proportion of patients that undergo a hematopoietic stem-cell transplant Up to 12 months following discontinuation of treatment
Secondary Transfusion independence To assess rate of transfusion independence Up to 12 months following discontinuation of treatment
Secondary Ziftomenib Cmax To assess the maximum plasma combination of ziftomenib and its metabolites Cycle 1 (Each cycle is 28 days)
Secondary Ziftomenib Tmax To assess the time to observed maximum plasma concentration of ziftomenib and its metabolites Cycle 1 (Each cycle is 28 days)
Secondary Ziftomenib AUC(0-last) To assess the area under the plasma concentration-time-curve from time 0 to time of last measurable concentration of ziftomenib and its metabolites Cycle 1 (Each cycle is 28 days)
Secondary Ziftomenib AUC(tau) To assess the area under the plasma concentration-time-curve over a dosing interval for ziftomenib and its metabolites Cycle 1 (Each cycle is 28 days)
Secondary Gilteritinib Cmax To assess the maximum plasma combination of gilteritinib Cycle 1 (Each cycle is 28 days)
Secondary Gilteritinib Tmax To assess the time to observed maximum plasma concentration of gilteritinib Cycle 1 (Each cycle is 28 days)
Secondary Gilteritinib AUC(0-last) To assess the area under the plasma concentration-time-curve from time 0 to time of last measurable concentration of gilteritinib Cycle 1 (Each cycle is 28 days)
Secondary Gilteritinib AUC(tau) To assess the area under the plasma concentration-time-curve over a dosing interval for gilteritinib Cycle 1 (Each cycle is 28 days)
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