The main purpose of the study is to investigate the safety and tolerability of AZD3514 when given orally to patients with castration-resistant prostate cancer (CRPC)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Patients will be given AZD3514 orally as a single dose, and then multiple once daily dosing following a 5-9 day washout.
Research Site
Portland, Oregon, United States
Research Site
Amsterdam, Netherlands
Research Site
Glasgow, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Surrey, United Kingdom
To investigate the safety and tolerability of AZD3514 when given orally to patients with CRPC.
Time frame: At every visit.
To define the MTD, if possible, a lower biologically-effective dose(s) or maximum feasible dose (if decided by the Safety Review Committee (SRC) and AstraZeneca).
Time frame: After each Cohort.
To characterise the PK of AZD3514 after a single oral dose and at steady state after multiple oral doses.
Time frame: After each Cohort.
To obtain an assessment of the activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate on the circulating levels of prostate-specific antigen (PSA).
Time frame: Visits 1, 4, 6, 7, 9, 10, follow-up visits, discontinuation visit
To obtain a preliminary assessment of the anti-tumour activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate by evaluation of counts of Circulating Tumour Cells (CTCs).
Time frame: Visits 1, 6, 8, 9, 10, follow-up visits, discontinuation visit
To obtain an assessment of the activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate on the circulating levels of prostate-specific antigen (PSA).
Time frame: Visits 1, 10, follow-up visits, discontinuation visit
To investigate safety, tolerability, MTD (and/or biologically-effective dose(s) or maximum feasible dose) and PK of AZD3514 and abiraterone when administered in combination, in patients who have not received prior treatment with abiraterone acetate
Time frame: At every visit
To compare the PK of AZD3514 monotherapy in patients who have been fed or fasted before the administration of study treatment
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Time frame: At visits 2 and 4
To investigate the effect of AZD3514 on biomarkers of AR expression in paired pre- and post-dose tumour biopsies.
Time frame: July 2012 - Feb 2013