drugset / Trial / NCT04060394

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC

NCT04060394

Phase 1/2 Completed 49 enrolled Laekna Limited
RandomizedSequentialOpen-labelTreatment

Summary

The combination treatment of protein kinase B (AKT) inhibitor, afuresertib, with androgen synthesis enzyme inhibitor, LAE001, may provide an effective treatment for metastatic castration resistant prostate cancer (m-CRPC) patients who have progressed/drug resistant following prior standard care treatments of any anti-androgen. This study intends to identify the most appropriate combined doses of LAE001/prednisone and afuresertib in m-CRPC patients who have progressive disease or are intolerant of 2 prior standard treatments of any anti-androgen or anti-androgen treatment plus chemotherapy.

Timeline

Start
2019-09-13
Primary completion
2023-12-27
Completion
2024-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Afuresertib Small molecule 100 mg
Subject Afuresertib Small molecule 125 mg
Subject Afuresertib Small molecule 150 mg
Subject CFG920 Small molecule 75 mg
Subject CFG920 Small molecule 100 mg
Subject Docetaxel Small molecule
Background Prednisone Other / unclassified 5 mg