ruserontinib (SKLB-1028)
/ CSPC Pharma
- LARVOL DELTA
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November 14, 2024
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."
Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3
November 07, 2019
Preliminary Analysis Results of a Phase I Study of the FLT3 Inhibitor SKLB1028 in Patients with Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
(ASH 2019)
- P1; "The results of our preliminary analysis suggested that SKLB1028 is safe, well-tolerated and effective for R/R FLT3-mutated AML patients. Larger studies are needed to more comprehensively assess the safety and efficacy of SKLB1028 in this population. This trial is registered at Clinical Trials.gov, number NCT02859948."
Clinical • P1 data • FLT3
May 11, 2022
A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
(clinicaltrials.gov)
- P1 | N=6 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
New P1 trial
November 05, 2021
A Dose Escalation and Food Effect Study of SKLB1028 in Healthy Subjects
(clinicaltrials.gov)
- P1; N=26; Completed; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Clinical • New P1 trial
November 02, 2021
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; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3
October 11, 2021
A Study of SKLB1028 in Patients With Advanced Solid Tumor
(clinicaltrials.gov)
- P1; N=98; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Clinical • New P1 trial • Gastrointestinal Cancer • Oncology • Solid Tumor
October 07, 2021
A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects
(clinicaltrials.gov)
- P1; N=14; Completed; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Clinical • New P1 trial
October 06, 2021
A Study to Investigate the Drug-drug Interactions (DDIs) of SKLB1028 With Itraconazole, Gemfibrozil or Rifampicin in Healthy Subjects
(clinicaltrials.gov)
- P1; N=42; Active, not recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Clinical • New P1 trial
January 20, 2021
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; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Clinical • New P3 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3
July 10, 2019
A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients
(clinicaltrials.gov)
- P2a; N=30; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Clinical • New P2a trial
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