NCT02525068

A Study of Enzalutamide in Combination With AZD5363 in Patients With mCRPC

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	AZD5363	Until confirmed disease progression.
DRUG	Enzalutamide	Until confirmed disease progression.

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-12-31
• Completion: 2020-03-01
• First posted: 2015-08-17
• Last updated: 2018-08-08

Locations

1 site across 1 country: United Kingdom