News - ruserontinib (SKLB-1028)

Evaluation of drug-drug interactions of a novel potent FLT3 inhibitor SKLB1028 in healthy subjects. (PubMed, Clin Transl Sci)

Based on the preclinical characterization of SKLB1028 metabolism, three drug-drug interaction clinical studies were performed to investigate the effects of itraconazole, rifampin (CYP3A4 inhibitor and inducer, respectively), and gemfibrozil (CYP2C8 inhibitor) on the metabolism of SKLB1028. Co-administration with rifampin reduced the AUC of SKLB1028 by ~30%, while the Cmax did not change significantly. All treatments were well tolerated in all three studies.

1 month ago

Journal

FLT3 (Fms-related tyrosine kinase 3)

FLT3-ITD mutation

itraconazole • rifampicin • ruserontinib (SKLB-1028)

3years

ALIVE: A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated (clinicaltrials.gov)

P3, N=315, Recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Recruiting

3 years ago

Clinical • Enrollment open

FLT3 (Fms-related tyrosine kinase 3)

FLT3 mutation

cytarabine • azacitidine • fludarabine IV • Synribo (omacetaxine mepesuccinate) • aclarubicin • ruserontinib (SKLB-1028)

almost4years

ALIVE: A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated (clinicaltrials.gov)

P3, N=315, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

almost 4 years ago

Clinical • New P3 trial

FLT3 (Fms-related tyrosine kinase 3)

FLT3 mutation

cytarabine • azacitidine • fludarabine IV • Synribo (omacetaxine mepesuccinate) • aclarubicin • ruserontinib (SKLB-1028)