NCT04060394

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

A Phase I/II Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib in Patients With Metastatic Castration-resistant Prostate Cancer Following Standard of Care Treatment

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Laekna Limited · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Phase I part of this study will perform a dose-escalation to identify the recommended Phase II dose of LAE001/prednisone plus afuresertib in m-CRPC patients. In the Phase II part of this study, the anti-tumor efficacy of LAE001/prednisone plus afuresertib and docetaxel/prednisone plus afuresertib will be assessed in mCRPC patients with PTEN loss and/or PIK3CA/AKT/PTEN alteration who have progressed on, or who are intolerant of, 1-3 prior standard treatments for mCSPC, or nmCRPC, or mCRPC, including at least one antiandrogen treatment and no more than one chemotherapy. Participants will be assigned to one of the two study cohorts, based on the investigator's clinical judgement. Cohort 1 will receive LAE001/prednisone plus afuresertib using RP2D established in the Phase I study. Cohort 2 will receive docetaxel/prednisone plus afuresertib, with a safety run-in period during the first cycle in the first 6 patients. These study results will provide preliminary efficacy and safety information of the combination of LAE001/prednisone plus afuresertib and docetaxel/prednisone plus afuresertib as requested in the Food and Drug Administration (FDA) combined therapy guideline. Whether to move one or both combination therapies to the pivotal study will be based on the PFS improvements of the combination therapy versus historical controls of abiraterone or docetaxel monotherapies in mCRPC patients who failed 1-3 lines of standard of care therapies.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Phase I and Phase II: LAE001/prednisone + afuresertib	In the Phase I portion of the study will identify the RPD2 of the combined therapy. In the Phase II will evaluate LAE001/prednisone + afuresertib at the RP2D (Cohort 1) and docetaxel/prednisone + afuresertib (Cohort 2).

Timeline

• Start date: 2019-09-13
• Primary completion: 2023-12-27
• Completion: 2024-03-30
• First posted: 2019-08-19
• Last updated: 2024-10-10

Locations

17 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study