An Open Label Prostate Cancer Study in Japanese Patients
Study identifier:D3760C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official 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 Japanese Patients with Metastatic Castration-Resistant Prostate Cancer
Medical condition
prostate cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD3514
Sex
Male
Actual Enrollment
16
Study type
Interventional
Age
20 Years - 150 Years
Date
Study Start Date: 01 Aug 2011
Primary Completion Date: 01 Mar 2013
Study Completion Date: 01 May 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 May 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD3514 Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD) | Drug: AZD3514 Patients will be given AZD3514 tablets or capsules administered orally as a single dose, and then multiple once-daily dosing following a 7 day washout. |
Contacts
Investigators
Principal Investigator
Glen Clack
AstraZeneca
