An Open Label Prostate Cancer Study in Japanese Patients

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351688
• Other study ID #: D3760C00003
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2011
• Last updated: July 2, 2013
• Start date: August 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Japan	Research Site	Sagamihara	Kanagawa
Japan	Research Site	Sunto-gun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Yes
Secondary	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)	during the single dose period and the first 21 days of multiple dosing (ie, by study day 29)	Yes
Secondary	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 (?z); (AUC(0-t)); total clearance and terminal phase (Vz) of AZD3514	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.	No
Secondary	To obtain an preliminary assessment of the anti-tumour activity of AZD3514		Every 12 weeks	No
Secondary	To obtain an assessment of the activity of AZD3514 on the circulating levels of prostate-specific antigen (PSA)		Day 8, 15, 29 and every 4 weeks	No

External Links

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