Population Pharmacokinetics of Asciminib in Tyrosine Kinase Inhibitor-Treated Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic and Acute Phases.
Ying Fei LiFrancois Pierre CombesMatthias HochSebastien LorenzoSherwin K B SyYu-Yun HoPublished in: Clinical pharmacokinetics (2022)
The final PopPK model adequately characterized the PK properties of asciminib and assessed the impact of key covariates on its exposure. The model corroborates the use of the approved asciminib dose of 80 mg total daily dose as 40 mg twice daily, and supports the use of 80 mg once daily as an alternative dose regimen to facilitate patient's compliance. TRIAL REGISTRATION NUMBER [DATE OF REGISTRATION]: First-in-human (CABL001X2101, Phase 1), ClinicalTrials.gov identifier: NCT02081378 [28 February 2014]; ASCEMBL (CABL001A2301, Phase 3), ClinicalTrials.gov identifier: NCT03106779 [10 April 2017].
Keyphrases
- chronic myeloid leukemia
- physical activity
- endothelial cells
- acute lymphoblastic leukemia
- clinical trial
- liver failure
- drug induced
- study protocol
- gene expression
- phase iii
- respiratory failure
- intensive care unit
- copy number
- phase ii
- extracorporeal membrane oxygenation
- hepatitis b virus
- aortic dissection
- double blind