AZD5363 in Patients with Metastatic Castrate-Resistant Prostate Cancer
Research type
Research Study
Full title
A Phase Ib Multicentre Study of AZD5363 Monotherapy to Assess Anti-Tumour Activity, Safety, Tolerability, and Pharmacokinetics in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC)(PYRUS)
IRAS ID
112140
Contact name
Simon Chowdhury
Sponsor organisation
AstraZeneca UK Limited
Eudract number
2011-004181-15
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
AZD5363 is a new anti cancer treatment being developed by AstraZeneca. This study is part of a research project for collecting information about the safety and effectiveness of this treatment for a variety of cancers. This study is investigating whether AZD5363 as monotherapy has the potential to provide an efficacy benefit in patients with mCRPC who have progressed on androgen-deprivation therapy pre or post-chemotherapy, in males 18 years of age and over. The main purpose of this study is to establish how metastatic castrate-resistant prostate cancer (mCRPC) responds to the drug. The study will also gather information on how well it is tolerated, any potential side effects it may cause, and will measure the levels of AZD5363 in the blood and the action of AZD5363 in the body over a period of time. There are two parts to this study, Part A and Part B. Part A will investigate how AZD5363 affects mCRPC in men who have already had chemotherapy for their disease. Part B will investigate how AZD5363 affects mCRPC in men who have not had previous chemotherapy for their disease. In addition, both parts of this study will investigate how AZD5363 is absorbed into the blood stream and acts in the body, and how well it is tolerated by men with mCRPC. The duration of the study is expected to be approximately 24 months.
REC name
London - Riverside Research Ethics Committee
REC reference
12/LO/1305
Date of REC Opinion
9 Oct 2012
REC opinion
Further Information Favourable Opinion