22 completed, 8 recruiting, 5 active not recruiting, 3 terminated. 25 Phase 1, 19 Phase 2, 5 Phase 3, 1 Early Phase 1.
Follow quizartinib: new trials by email Literature Review of quizartinib trials Research Report on quizartinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Testing the Investigational Medication Combination of Azacitidine, Venetoclax, and Quizartinib Compared to the Usual Treatment of Cytarabine, Daunorubicin, and Quizartinib for Patients With FLT3-ITD Mutant Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) Azacitidine, Biospecimen Collection, Bone Marrow Aspiration - Acute Myeloid Leukemia | Phase 2 | Not yet recruiting | National Cancer Institute (NCI) | 122 | 2027-01-15 | 2026-10-07 |
| Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI) Azacitidine, Venetoclax, Quizartinib - Acute Myeloid Leukemia, Adult | Phase 3 | Recruiting | PETHEMA Foundation | 376 | 2026-07-02 | 2026-11-04 |
| Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission Quizartinib High Dose, Quizartinib Low Dose - Acute Myeloid Leukemia, Leukemia | Phase 2 | Recruiting | Daiichi Sankyo | 130 | 2025-07-18 | 2026-09-16 |
| Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia Ziftomenib, Quizartinib - Acute Myeloid Leukemia | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 44 | 2025-07-10 | 2026-09-18 |
| Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML Quizartinib, Placebo, Chemotherapy - Leukemia | Phase 3 | Active not recruiting | Daiichi Sankyo | 700 | 2024-11-19 | 2026-07-02 |
| Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects Quizartinib, Rufinamide - Healthy Subjects | Phase 1 | Completed | Daiichi Sankyo | 32 | 2024-10-29 | 2024-12-18 |
| A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate Quizartinib, Placebo - Healthy Subjects | Phase 1 | Completed | Daiichi Sankyo | 70 | 2024-10-24 | 2025-08-01 |
| Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment Quizartinib - Hepatic Impairment | Phase 1 | Recruiting | Daiichi Sankyo | 12 | 2024-09-30 | 2026-04-01 |
| MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) Allogeneic Hematopoietic Stem Cell Transplantation, Azacitidine, Best Practice - Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm | Phase 2 | Recruiting | National Cancer Institute (NCI) | 2000 | 2024-06-18 | 2026-11-02 |
| CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients Quizartinib, Etoposide, Dexrazoxane - Acute Myeloid Leukemia in Children | Phase 2 | Recruiting | Princess Maxima Center for Pediatric Oncology | 60 | 2024-02-06 | 2025-08-05 |
| A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML Ziftomenib, Venetoclax, Azacitidine - Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation | Phase 1 | Recruiting | Kura Oncology, Inc. | 420 | 2023-07-18 | 2026-03-13 |
| Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs Physician's Choice in Newly Diagnosed FLT3-ITD+ AML Quizartinib, Treatment according to Physician's Choice, Standard of Care Chemotherapy - Acute Myeloid Leukemia | Phase 3 | Withdrawn | University Hospital Heidelberg | 2022-05-01 | 2022-05-25 | |
| A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects Quizartinib dihydrochloride, 14C-Quizartinib solution for infusion - Healthy Subjects | Phase 1 | Completed | Daiichi Sankyo | 8 | 2021-04-26 | 2023-01-11 |
| Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old Azacitidine, Venetoclax, Quizartinib - Leukemia, Myeloid, Acute, De Novo | Phase 1 / Phase 2 | Completed | PETHEMA Foundation | 113 | 2020-11-04 | 2026-05-13 |
| A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment Quizartinib - Hepatic Impairment, Moderate Impaired Hepatic Function | Phase 1 | Completed | Daiichi Sankyo | 12 | 2020-09-22 | 2023-08-01 |
| A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants Dabigatran Etexilate Mesylate, Quizartinib - Healthy Subjects, Drug-drug Interaction | Early Phase 1 | Completed | Daiichi Sankyo Co., Ltd. | 20 | 2020-08-28 | 2021-07-09 |
| A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants Efavirenz, Quizartinib - Healthy Subjects, Drug-drug Interaction | Phase 1 | Completed | Daiichi Sankyo Co., Ltd. | 32 | 2020-08-19 | 2022-06-28 |
| Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations Azacitidine, Quizartinib - Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome | Phase 1 / Phase 2 | Active not recruiting | M.D. Anderson Cancer Center | 30 | 2020-07-21 | 2026-10-05 |
| A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia CPX-351, Quizartinib - Leukemia, Myeloid, Acute | Phase 2 | Terminated | SCRI Development Innovations, LLC | 1 | 2020-06-03 | 2023-12-05 |
| Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome Liposome-encapsulated Daunorubicin-Cytarabine, Quizartinib - Acute Myeloid Leukemia, Blasts More Than 10 Percent of Bone Marrow Nucleated Cells | Phase 1 / Phase 2 | Active not recruiting | M.D. Anderson Cancer Center | 52 | 2020-05-27 | 2026-06-02 |
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Leukemia, Myeloid, Acute (30) · Leukemia (8) · Recurrence (7) · Myelodysplastic Syndromes (6) · Leukemia, Myelomonocytic, Chronic (2) · Myeloproliferative Disorders (2) · Aortic aneurysm, familial thoracic 4 (1) · Hematologic Neoplasms (1) · Leukemia, Biphenotypic, Acute (1) · Leukemia, Erythroblastic, Acute (1) · Leukemia, Myeloid (1) · Neoplasms (1) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (1) · Primary Myelofibrosis (1) · Sarcoma, Myeloid (1)
Daiichi Sankyo (18) · M.D. Anderson Cancer Center (7) · Daiichi Sankyo Co., Ltd. (5) · PETHEMA Foundation (4) · National Cancer Institute (NCI) (2) · Children's Oncology Group (1) · Kura Oncology, Inc. (1) · Princess Maxima Center for Pediatric Oncology (1) · SCRI Development Innovations, LLC (1) · The University of Hong Kong (1) · Therapeutic Advances in Childhood Leukemia Consortium (1) · University Hospital Heidelberg (1)
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Musa Yilmaz (3) · Guy Gammon, MB, BS, MRCP (2) · Pau Montesinos, MD (2) · Anskar Leung, Professor (1) · Claudia Sossa (1) · Gertjan Kaspers, Prof. Dr. (1) · Ghayas Issa, MD (1) · Guillermo M Bravo (1) · Guy Gammon, MB BS, MRCP (1) · Jerald P Radich (1)
PMID 29859851, PMID 24002496, PMID 26920889, PMID 30081867, PMID 31175001, PMID 33208914, PMID 33415416, PMID 36902217, PMID 37116523, PMID 38744144, PMID 40079105, PMID 40327322, PMID 41052406, PMID 41082703, PMID 41791832, PMID 41949390, PMID 42227701, PMID 42321916, PMID 42374628, PMID 42434847
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