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Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT06001788 · Kura Oncology, Inc.
In plain English
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Official title
Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia
About this study
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.
Eligibility criteria
Key Inclusion Criteria:
* Has been diagnosed with relapsed/refractory AML.
* 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.
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
Enrollment target: 171 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-22
Estimated completion: 2027-08
Last updated: 2026-04-14
Interventions
Drug: ZiftomenibDrug: FludarabineDrug: IdarubicinDrug: CytarabineDrug: GilteritinibBiological: Granulocyte colony-stimulating factor
Primary outcomes
- • Rate of dose limiting toxicities (DLTs) per dose level (During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle))
- • Descriptive statistics of adverse events (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)
Sponsor
Kura Oncology, Inc. · industry
Contacts & investigators
ContactKura Medical Information · contact · medinfo@kuraoncology.com · 844-KURAONC (844-587-2662)
All locations (45)
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
UCLA Health - Bowyer Oncology CenterRecruiting
Los Angeles, California, United States
UC Irvine Health Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
Smilow Cancer Hospital at Yale New HavenRecruiting
New Haven, Connecticut, United States
Emory Healthcare - The Emory ClinicRecruiting
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta UniversityRecruiting
Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityRecruiting
Chicago, Illinois, United States
Loyola University Medical CenterRecruiting
Maywood, Illinois, United States
Simmons Cancer InstituteWithdrawn
Springfield, Illinois, United States
University of Iowa Hospitals & ClinicsRecruiting
Iowa City, Iowa, United States
The University of Kansas Cancer CenterRecruiting
Kansas City, Kansas, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Henry Ford Cancer InstituteRecruiting
Detroit, Michigan, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, United States
Northwell Health, LLC PRIMERecruiting
Lake Success, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Weill Cornell Medical College-NY Presbyterian HospitalRecruiting
New York, New York, United States
Wilmot Cancer Institute, University of RochesterRecruiting
Rochester, New York, United States
Stony Brook Cancer CenterRecruiting
Stony Brook, New York, United States
Atrium Health Levine Cancer CenterRecruiting
Charlotte, North Carolina, United States
UH Seidman Cancer CenterRecruiting
Cleveland, Ohio, United States
OU Health Stephenson Cancer CenterRecruiting
Oklahoma City, Oklahoma, United States
Lehigh Valley Topper Cancer InstituteWithdrawn
Allentown, Pennsylvania, United States
Prisma HealthRecruiting
Greenville, South Carolina, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of VermontRecruiting
Burlington, Vermont, United States
University of Virginia Comprehensive Cancer CenterRecruiting
Charlottesville, Virginia, United States
University of WashingtonRecruiting
Seattle, Washington, United States
Froedtert & Medical College ClinicsRecruiting
Milwaukee, Wisconsin, United States
IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'OrsolaRecruiting
Bologna, Italy
Ospedale Santa Maria delle CrociRecruiting
Ravenna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Roma, Italy
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Spain
Hospital Universitario Virgen del RocíoRecruiting
Seville, Spain
Hospital Universitari y Politecnic La FeRecruiting
Valencia, Spain