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Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)

Patients will be given AZD3514 orally as a single dose, and then multiple once daily dosing following a 5-9 day washout.

AZD3514

Tony Elliott, MD

Glen Clack, MD

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)

Open Label Prostate Cancer Study

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.

AstraZeneca

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.

Takefumi Sato, MD

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.

An Open Label Prostate Cancer Study in Japanese Patients

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

Number of participants with adverse events

A DLT is defined as any toxicity not attributable to the disease or disease-related processes under investigation and considered to be related to AZD3514 therapy during the single dose period and the first 21 days of multiple dosing (ie, by study day 29)

To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses

* Cmax
* Cmax at steady state (Cmax, ss)
* time to maximum concentration (tmax)
* tmax at steady state (tmax, ss)
* terminal elimination rate constant (λz)
* (AUC(0-t))
* total clearance and terminal phase (Vz) of AZD3514

Spots Global Cancer Trial Database for azd3514

Every month we try and update this database with for azd3514 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open Label Prostate Cancer Study	NCT01162395	Prostate Cancer	AZD3514	20 Years - 130 Years	AstraZeneca
An Open Label Prostate Cancer Study in Japanese Patients	NCT01351688	Prostate Cancer	AZD3514	20 Years -	AstraZeneca
Open Label Prostate Cancer Study	NCT01162395	Prostate Cancer	AZD3514	20 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for azd3514

Every month we try and update this database with for azd3514 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd3514 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.