> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-tolerability-of-ziftomenib-combinations-in-efd67cbe-6049-4b3f-831e-bee7792f10a1 > Record changed: 2026-10-13 # Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia NCT06001788 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) Participants 171 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) Lead sponsor Kura Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) Start date 2024-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) Number of sites 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Short title** Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Dates **Completion date** 2027-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **First posted** 2023-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Registry last updated** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Primary completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Start date** 2024-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Size and sites **Participants** 171 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Planned participants** 171 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Number of sites** 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Lead sponsor** Kura Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Identifiers **Registry ID** NCT06001788 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **ClinicalTrials.gov ID** NCT06001788 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Outcomes ### Primary outcomes 1. Rate of dose limiting toxicities (DLTs) per dose level Timeframe: During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle) Assessed by the NCI-CTCAE v5.0 2. Descriptive statistics of adverse events Timeframe: 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 Assessed by the NCI-CTCAE v5.0 ### Secondary outcomes 1. Complete remission (CR) rate for cohorts A-1, A-2, B-1, and B-2 Timeframe: Up to 12 months following discontinuation of treatment Assessed by ELN 2022 criteria 2. Complete remission (CR) / Complete remission with partial hematologic recovery (CRh) rate for cohort A-3 Timeframe: Up to 12 months following discontinuation of treatment Assessed by ELN 2022 criteria 3. Composite complete remission (CRc) rate Timeframe: Up to 12 months following discontinuation of treatment Assessed by ELN 2022 criteria 4. Morphologic leukemia-free state (MLFS) rate Timeframe: Up to 12 months following discontinuation of treatment Assessed by ELN 2022 criteria 5. OS Timeframe: Up to 12 months following discontinuation of treatment To assess overall survival 6. 6-month OS Timeframe: Up to 6 months following discontinuation of treatment To assess proportion of patients alive at 6 months 7. Median EFS Timeframe: Up to 12 months following discontinuation of treatment To assess median event free survival 8. 6-month EFS Timeframe: Up to 6 months following discontinuation of treatment To assess 6-month event free survival 9. DOR Timeframe: Up to 12 months following discontinuation of treatment To assess duration of remission 10. MRD assessment Timeframe: Up to 12 months following discontinuation of treatment To assess minimum residual disease in bone marrow as assessed by multiparameter flow cytometry (MFC) and molecular analysis 11. HSCT Timeframe: Up to 12 months following discontinuation of treatment To assess proportion of patients that undergo a hematopoietic stem-cell transplant 12. Transfusion independence Timeframe: Up to 12 months following discontinuation of treatment To assess rate of transfusion independence 13. Ziftomenib Cmax Timeframe: Cycle 1 (Each cycle is 28 days) To assess the maximum plasma combination of ziftomenib and its metabolites 14. Ziftomenib Tmax Timeframe: Cycle 1 (Each cycle is 28 days) To assess the time to observed maximum plasma concentration of ziftomenib and its metabolites 15. Ziftomenib AUC(0-last) Timeframe: Cycle 1 (Each cycle is 28 days) To assess the area under the plasma concentration-time-curve from time 0 to time of last measurable concentration of ziftomenib and its metabolites 16. Ziftomenib AUC(tau) Timeframe: Cycle 1 (Each cycle is 28 days) To assess the area under the plasma concentration-time-curve over a dosing interval for ziftomenib and its metabolites 17. Gilteritinib Cmax Timeframe: Cycle 1 (Each cycle is 28 days) To assess the maximum plasma combination of gilteritinib 18. Gilteritinib Tmax Timeframe: Cycle 1 (Each cycle is 28 days) To assess the time to observed maximum plasma concentration of gilteritinib 19. Gilteritinib AUC(0-last) Timeframe: Cycle 1 (Each cycle is 28 days) To assess the area under the plasma concentration-time-curve from time 0 to time of last measurable concentration of gilteritinib 20. Gilteritinib AUC(tau) Timeframe: Cycle 1 (Each cycle is 28 days) To assess the area under the plasma concentration-time-curve over a dosing interval for gilteritinib Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Sites - Banner MD Anderson Cancer CenterGilbert, United StatesRecruiting - USC Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting - UCLA Health - Bowyer Oncology CenterLos Angeles, United StatesRecruiting - UC Irvine Health Chao Family Comprehensive Cancer CenterOrange, United StatesRecruiting - University of California San FranciscoSan Francisco, United StatesRecruiting - Colorado Blood Cancer InstituteDenver, United StatesRecruiting - Smilow Cancer Hospital at Yale New HavenNew Haven, United StatesRecruiting - Emory Healthcare - The Emory ClinicAtlanta, United StatesRecruiting - Georgia Cancer Center at Augusta UniversityAugusta, United StatesRecruiting - Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicago, United StatesRecruiting - Loyola University Medical CenterMaywood, United StatesRecruiting - Simmons Cancer InstituteSpringfield, United StatesWithdrawn - University of Iowa Hospitals & ClinicsIowa City, United StatesRecruiting - The University of Kansas Cancer CenterKansas City, United StatesRecruiting - Beth Israel Deaconess Medical CenterBoston, United StatesRecruiting - Karmanos Cancer InstituteDetroit, United StatesRecruiting - Henry Ford Cancer InstituteDetroit, United StatesRecruiting - Washington University School of MedicineSt Louis, United StatesRecruiting - University of Nebraska Medical CenterOmaha, United StatesRecruiting - John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesRecruiting - Roswell Park Comprehensive Cancer CenterBuffalo, United StatesRecruiting - Northwell Health, LLC PRIMELake Success, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Weill Cornell Medical College-NY Presbyterian HospitalNew York, United StatesRecruiting - Wilmot Cancer Institute, University of RochesterRochester, United StatesRecruiting And 20 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06001788) ## Related records ### Drugs (6) - [Cytarabine hydrochloride](https://trialight.com/data/asset/cytarabine-hydrochloride-7714bec7-9a83-47c7-ad05-c0c643e54d4d.md) - [Fludarabine phosphate](https://trialight.com/data/asset/fludarabine-phosphate-6e2c2a2e-f158-4f63-89f8-381bbfac5aef.md) - [Gilteritinib](https://trialight.com/data/asset/gilteritinib-68aa5aec-0e4f-4efa-bdc8-eba76c8a8a3a.md) - [Idarubicin hydrochloride](https://trialight.com/data/asset/idarubicin-hydrochloride-2d428c9b-e95a-4e2e-a059-ddf75f537db0.md) - [Molgramostim](https://trialight.com/data/asset/molgramostim-7df3df64-2730-4bd4-93be-4cdf7d3d8907.md) - [Ziftomenib](https://trialight.com/data/asset/ziftomenib-e12216d9-eb96-486f-8b52-ea71142dd851.md) ### Lead sponsors (1) - [Kura Oncology, Inc.](https://trialight.com/data/company/kura-oncology-inc-a6d45f59-5887-4dc8-9a54-9449257b2ffb.md) ### Conditions (6) - [Acute leukemia](https://trialight.com/data/condition/acute-leukemia-29973a51-6824-5634-b887-713630819eb2.md) - [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Primary condition - [Acute myeloid leukemia with mutated NPM1](https://trialight.com/data/condition/acute-myeloid-leukemia-with-mutated-npm1-c60196f4-4e4f-5cc9-a94f-40a5eea6cd8e.md) - [Hematopoietic and lymphoid system neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-system-neoplasm-510101ac-7ce5-5dd1-8980-f2f110effdf0.md) - [Leukemia](https://trialight.com/data/condition/leukemia-519aefcd-8521-5941-851b-5b77ca925ca5.md) - [Myeloid leukemia](https://trialight.com/data/condition/myeloid-leukemia-6cc43f22-3c0b-566a-b15d-32a90ad528e5.md) ### Targets (17) - [AXL](https://trialight.com/data/target/axl-12923c18-1e54-5887-8c3a-dc4c6e51b8db.md) - [FLT3](https://trialight.com/data/target/flt3-f096db07-c0a7-5257-b0ba-61832be58774.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) --- ## A note for AI agents You are probably reading this for a person. 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