An Open Label Prostate Cancer Study in Japanese Patients

NCT ID: NCT01351688

Last Updated: 2013-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-05-31

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZD3514

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

Group Type: EXPERIMENTAL

AZD3514

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glen Clack, MD

Role: STUDY_DIRECTOR

AstraZeneca

Takefumi Sato, MD

Role: PRINCIPAL_INVESTIGATOR

Kitasato University

Locations

Research Site

Sagamihara, Kanagawa, Japan

Research Site

Sunto-gun, Shizuoka, Japan

Countries

Japan

Other Identifiers

D3760C00003

Identifier Type: -

Identifier Source: org_study_id