Study identifier:D3760C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
prostate cancer
Phase 1
No
AZD3514
Male
16
Interventional
20 Years - 150 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2014 by AstraZeneca
AstraZeneca
-
The primary aim of study is to gain an initial assessment of safety and tolerability of AZD3514 in Japanese patients together with assessing Pharmacokinetics (PK) and gaining a preliminary assessment of anti-tumour action. In this study, AZD3514 will be administered to Japanese patients with metastatic castration resistant prostate cancer.
Location
Location
Sagamihara-shi, Japan
Location
Sunto-gun, Japan
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. |
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