Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT06001788
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
171 participants
INTERVENTIONAL
2024-02-22
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b
Oral ziftomenib; Following the determination of the maximum tolerated dose in Phase 1a, participants will be enrolled in 1 of 5 dose validation/expansion cohorts:
A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA
A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC)
A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib
B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA
B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)
Ziftomenib
Oral administration
Fludarabine
Intravenous infusion
Idarubicin
Intravenous infusion
Cytarabine
Intravenous Infusion
Gilteritinib
Oral administration
Granulocyte colony-stimulating factor
Subcutaneous injection
Phase 1a
Oral ziftomenib; sequential cohorts of escalating dose levels of ziftomenib to identify the safety and tolerability of the combination regimens. Participants will be enrolled in 1 of 5 dose escalation cohorts:
A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA
A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC)
A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib
B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA
B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)
Ziftomenib
Oral administration
Fludarabine
Intravenous infusion
Idarubicin
Intravenous infusion
Cytarabine
Intravenous Infusion
Gilteritinib
Oral administration
Granulocyte colony-stimulating factor
Subcutaneous injection
Interventions
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Ziftomenib
Oral administration
Fludarabine
Intravenous infusion
Idarubicin
Intravenous infusion
Cytarabine
Intravenous Infusion
Gilteritinib
Oral administration
Granulocyte colony-stimulating factor
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a documented NPM1 mutation or KMT2A rearrangement.
* Has a documented FLT3 mutation (cA-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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Kura Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Health - Bowyer Oncology Center
Los Angeles, California, United States
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Emory Healthcare - The Emory Clinic
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Simmons Cancer Institute
Springfield, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
The University of Kansas Cancer Center
Kansas City, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Northwell Health, LLC PRIME
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College-NY Presbyterian Hospital
New York, New York, United States
Wilmot Cancer Institute, University of Rochester
Rochester, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Atrium Health Levine Cancer Center
Charlotte, North Carolina, United States
UH Seidman Cancer Center
Cleveland, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Lehigh Valley Topper Cancer Institute
Allentown, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
Froedtert & Medical College Clinics
Milwaukee, Wisconsin, United States
IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola
Bologna, , Italy
Ospedale Santa Maria delle Croci
Ravenna, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari y Politecnic La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Christine Duran
Role: primary
Bruck Habtemariam
Role: primary
Research Line
Role: primary
New Patient Contact
Role: primary
Farah Fasihuddin
Role: primary
Gigi Stoneback
Role: primary
Amanda Spires
Role: primary
Role: primary
Esteban Orozco Espiricueta
Role: primary
Mohammed Hussain
Role: primary
Grerk Sutamtewagul
Role: primary
KUCC Navigation Team
Role: primary
Cathy Galasso
Role: primary
Kristyn Dailey
Role: primary
Oncology Clinical Reference Referral Office
Role: primary
Role: primary
Role: primary
Tania Curcio
Role: primary
Clinical Trials Referral Office
Role: primary
Zita Makselyte
Role: primary
Chari Granger
Role: primary
Leslie Ortega
Role: primary
Cynthia J Lowery
Role: primary
Alexandra Bauman
Role: primary
Lisa Johnson
Role: primary
Fiona Davidson
Role: backup
Recruitment and Eligibility Office
Role: primary
Christine Terraciano
Role: primary
Ann Mosely
Role: primary
Stephanie Stahl
Role: primary
Avani Hopkins
Role: primary
Cristina Papayannidis
Role: primary
Francesco Lanza
Role: primary
Simona Sica
Role: primary
Olga Salamero
Role: primary
Teresa Bernal del Castillo
Role: primary
Eduardo Rodríguez-Arbolí
Role: primary
Pau Montesinos Fernandez
Role: primary
Other Identifiers
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KO-MEN-008
Identifier Type: -
Identifier Source: org_study_id