drugset / Trial / NCT02081378
A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic leukemia (Ph+ ALL) patients who are relapsed or refractory to or are intolerant of Tyrosine kinase inhibitors (TKIs), and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.
Timeline
- Start
- 2014-04-24
- Primary completion
- 2021-06-03
- Completion
- 2023-03-14
Publications
- Luskin MR, Murakami MA, Keating J, Flamand Y, Winer ES, Garcia JS, Stahl M, Stone RM, Wadleigh M, Jaeckle SL, Hagopian E, Weinstock DM, Liegel J, McMasters M, Wang ES, Stock W, DeAngelo DJ. Asciminib plus dasatinib and prednisone for Philadelphia chromosome-positive acute leukemia. Blood. 2025 Feb 6;145(6):577-589. doi: 10.1182/blood.2024025800.
- Cortes JE, Sasaki K, Kim DW, Hughes TP, Etienne G, Mauro MJ, Hochhaus A, Lang F, Heinrich MC, Breccia M, Deininger M, Goh YT, Janssen JJWM, Talpaz M, de Soria VGG, le Coutre P, DeAngelo DJ, Damon A, Cacciatore S, Polydoros F, Agrawal N, Rea D. Asciminib monotherapy in patients with chronic-phase chronic myeloid leukemia with the T315I mutation after >/=1 prior tyrosine kinase inhibitor: 2-year follow-up results. Leukemia. 2024 Jul;38(7):1522-1533. doi: 10.1038/s41375-024-02278-8. Epub 2024 May 16.
- Li YF, Combes FP, Hoch M, Lorenzo S, Sy SKB, Ho YY. Population Pharmacokinetics of Asciminib in Tyrosine Kinase Inhibitor-Treated Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic and Acute Phases. Clin Pharmacokinet. 2022 Oct;61(10):1393-1403. doi: 10.1007/s40262-022-01148-9. Epub 2022 Jun 28.
- Hughes TP, Mauro MJ, Cortes JE, Minami H, Rea D, DeAngelo DJ, Breccia M, Goh YT, Talpaz M, Hochhaus A, le Coutre P, Ottmann O, Heinrich MC, Steegmann JL, Deininger MWN, Janssen JJWM, Mahon FX, Minami Y, Yeung D, Ross DM, Tallman MS, Park JH, Druker BJ, Hynds D, Duan Y, Meille C, Hourcade-Potelleret F, Vanasse KG, Lang F, Kim DW. Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure. N Engl J Med. 2019 Dec 12;381(24):2315-2326. doi: 10.1056/NEJMoa1902328.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asciminib | Unknown | 10 mg | Oral |
| Subject | Asciminib | Unknown | 200 mg | Oral |
| Background | Imatinib | Small molecule | — | Oral |
| Background | Nilotinib | Small molecule | — | Oral |
| Background | dasatinib anhydrous | Small molecule | — | Oral |