RE-AKT
Research type
Research Study
Full title
A randomised Phase II study of Enzalutamide (MDV3100) in combination with AZD5363 in Patients with Metastatic Castration - Resistant Prostate Cancer
IRAS ID
134883
Contact name
Johann de Bono
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2013-004091-34
ISRCTN Number
n/a
Research summary
Prostate cancer is the most common male cancer in the UK with more than 11,000 deaths every year. The two most common genetic defects in this disease are androgen receptor (AR) driven rearranged oncogenes and PI3K/AKT pathway activation. Currently in the UK docetaxel followed by abiraterone is the standard of care for patients with advanced prostate cancer (APC). For patients with disease progression after treatment with abiraterone and docetaxel, options are cabazitaxel, participation in clinical trials or supportive care.
About 50% of post-chemotherapy patients with APC will be eligible for RE-AKT; a trial of enzalutamide with the novel AKT inhibitor AZD5363.
Enzalutamide is an anti-androgen with distinct properties that blocks testosterone binding to the AR, impacts AR transport into the nucleus and inhibits binding of the AR to DNA. AZD5363 inhibits the AKT protein which helps cancer cells grow, multiply and spread.. By combining enzalutamide and AZD5363 it is hoped the cancer cells stop growing and the growth and spread of those that do is slowed.
RE-AKT has three parts;
- Phase I safety-run in phase to determine the dose of AZD5363 to use
- Phase II randomised, double blind trial to measure how effective the combination treatment is
- Single stage phase II expansion cohort where AZD5363 is added to enzaluatmaide at progression to explore whether AZD5363 can reverse resistance to enzalutamide.Enzalutamide and AZD5363 are taken orally and are taken as long as they are helping to prevent the cancer getting worse. Participants will have regular check-ups at the hospital. Participants will be asked to donate blood, urine, tumour, hair, buccal (cheek) swab and saliva samples during the study to see if there are any drug to drug interactions and to see if there is anything that will predict who this combination treatment will work best for.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/0259
Date of REC Opinion
19 Mar 2014
REC opinion
Favourable Opinion