Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-28 @ 7:06 AM
Study NCT ID:
NCT02525068
Status:
UNKNOWN
Last Update Posted:
2018-08-08
First Post:
2015-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Enzalutamide in Combination With AZD5363 in Patients With mCRPC
Sponsor:
Institute of Cancer Research, United Kingdom
Organization:
Study Overview
Official Title:
A Randomised Phase II Study of Enzalutamide (MDV3100) in Combination With AZD5363 in Patients With Metastatic Castration-Resistant Prostate Cancer (RE-AKT)
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-AKT
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: