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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


Phase 1
20 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

Number of participants with adverse events

Outcome 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

Safety Issue:

Yes

Principal Investigator

Glen Clack, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D3760C00003

NCT ID:

NCT01351688

Start Date:

August 2011

Completion Date:

November 2012

Related Keywords:

  • Prostate Cancer
  • Phase 1
  • Metastatic
  • Castration resistant
  • Prostate cancer
  • Androgen receptor
  • Down regulation
  • Japanese
  • Prostatic Neoplasms

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