Safety & Tolerability of AZD3514 in Castrate Resistant Prostate Cancer
Research type
Research Study
Full title
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD3514 in Patients with Metastatic Castration-Resistant Prostate Cancer.
IRAS ID
47914
Contact name
Paul Anthony (Tony) Elliott
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2010-020232-19
ISRCTN Number
N/A
Research summary
AstraZeneca is conducting a research study with AZD3514, a new anticancer agent, in patients with metastatic, castrate-resistant prostate cancer. Laboratory studies have shown that AZD3514 suppresses the growth of prostate cancer cells as well as PSA release and may inhibit tumours that have proven resistant to previous therapies. Therefore, patients may derive benefit from this study, but there is no guarantee. This study is designed to show the safety and tolerability of AZD3514 and to identify a dose that may be used in future studies. As this drug has never before been given to humans, it will start with a small dose for one patient then 7 days later if all is well further patients in this group will be dosed. Dose escalation is planned for subsequent study cohorts and will continue until a maximum tolerated dose is identified. The number of patients studied at a dose level determined to be biologically effective will be expanded to confirm the suitability of the dose(s) for further study. We are also conducting the study to determine how the body handles AZD3514, i.e., how quickly the body absorbs and eliminates the drug. We will also be studying how the body responds to AZD3514 and how genes (pieces of DNA) may affect the way the body responds to the drug or handles it. Patients will be recruited from 3 clinical centres in the United Kingdom and The Netherlands. If patients consent to enter this study, they will attend hospital visits throughout the study; visits will be most frequent during the first 28 days. At these visits patients will undergo assessments to check on their health and to see how the drug is working. Patients may remain on AZD3514 treatment as long as they are receiving benefit and are not experiencing unacceptable side effects.
REC name
West of Scotland REC 1
REC reference
10/S0703/42
Date of REC Opinion
18 Aug 2010
REC opinion
Further Information Favourable Opinion