Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies

Phase 1/2 Terminated 124 enrolled Sun Pharma Advanced Research Company Limited

NaSingle-groupOpen-labelTreatment

Summary

Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

Timeline

Start: 2016-06-27
Primary completion: 2025-01-03
Completion: 2025-01-03

Outcome

Outcome not reported

Stopped: “Closed for administrative, non-safety-related reasons.”

Publications

Cortes JE, Kim DW, Saikia T, Khattry N, Rathnam K, Alvarado Y, Hannah G, Tantravahi SK, Apperley JF, Charbonnier A, Garcia-Gutierrez V, Lucchesi A, Dima D, Illes A, Popov VM, Abruzzese E, Nag A, Apte S, Badar T, Yao SL, Saxena U, Sreenivasan J, Inamdar S, Chimote G, Nicolini FE. Vodobatinib for patients with Philadelphia chromosome-positive chronic myeloid leukaemia resistant or intolerant to multiple lines of previous therapy: an open-label, multicentre, phase 1/2 trial. Lancet Haematol. 2025 Mar;12(3):e201-e213. doi: 10.1016/S2352-3026(24)00354-5. Epub 2025 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vodobatinib	Small molecule	12 mg	Oral
Subject	Vodobatinib	Small molecule	174 mg	Oral
Subject	Vodobatinib	Small molecule	204 mg	Oral
Subject	Vodobatinib	Small molecule	240 mg	Oral