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A Study of Enzalutamide in Combination With AZD5363 in Patients With mCRPC — RE-AKT  

Adenocarcinoma of the Prostate Clinical Trial

Official title:
A Randomised Phase II Study of Enzalutamide (MDV3100) in Combination With AZD5363 in Patients With Metastatic Castration‐Resistant Prostate Cancer (RE‐AKT)

Clinical Trial Summary

A multicentre prospective, randomised, phase II interventional study in mCRPC patients previously treated with 1‐2 lines of chemotherapy and at least 12 weeks of abiraterone with a safety run‐in and single stage phase II expansion cohort.

Clinical Trial Description

Patients with mCRPC will receive enzalutamide and AZD5363 (or enzalutamide and placebo in the randomised phase II) until confirmed disease progression.

The trial aims to identify the safety and tolerability of enzalutamide and AZD5363 and identify recommended phase II dose of AZD5363 (phase I safety run-in). The randomised phase II will estimate and compare the anti-tumour activity of AZD5363 and enzalutamide, and placebo and enzalutamide as measured by response. The single stage phase II expansion cohort will estimate the anti-tumour activity of AZD5363 and enzalutamide in patients who have previously progressed on enzalutamide alone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02525068
Study type Interventional
Source Institute of Cancer Research, United Kingdom
Contact RE-AKT Trial Manager
Email RE-AKT-icrctsu@icr.ac.uk
Status Recruiting
Phase Phase 2
Start date December 2014
Completion date March 2020
View Details
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