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 —