An Open Label Prostate Cancer Study in Japanese Patients

AstraZeneca13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

AZD3514DRUG

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.

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males aged 20 years or older. * Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate * Documented evidence of metastatic prostate cancer * Serum testosterone concentration ≤50 ng/dL * World Health Organisation (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks Exclusion Criteria: * History of hypersensitivity to active or inactive excipients of AZD3514 or drugs with a similar chemical structure or class to AZD3514 * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD3514 * Inadequate bone marrow reserve or organ function * Concurrent or recent treatment with certain medications or medical procedures * Any medically important factors identified from electrocardiogram (ECG) measurements

Locations (2)

Research Site

Sagamihara, Kanagawa, Japan

Research Site

Sunto-gun, Shizuoka, Japan

Outcomes

Primary Outcomes

To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer

Number of participants with adverse events

Time frame: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified

Secondary Outcomes

To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514

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)

Time frame: 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

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

Time frame: Multiple timepoints taken, begining at Day 1 and until 48 hrs after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

To obtain an preliminary assessment of the anti-tumour activity of AZD3514

Time frame: Every 12 weeks

To obtain an assessment of the activity of AZD3514 on the circulating levels of prostate-specific antigen (PSA)

Time frame: Day 8, 15, 29 and every 4 weeks

Data from ClinicalTrials.gov

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