An Open Label Prostate Cancer Study in Japanese Patients

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: AZD3514

Study type

Interventional

Funder types

Industry

Identifiers

NCT01351688

D3760C00003

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

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