Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy,
in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated
in patients who have progressed after chemotherapy (Part A) and in patients who have
progressed before receiving chemotherapy (Part B).
Recruitment into Part A, Group 1 has been suspended. A new design for this group is currently
being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd generational
anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days on/3days off).
Part B will only start if there is evidence of anti-tumour activity along with AZD5363 having
an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy patients
on a dose and schedule selected from Part A.