An Open Label Prostate Cancer Study in Japanese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01351688
First received: April 11, 2011
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: AZD3514
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer [ 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 ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events


Secondary Outcome Measures:
  • To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514 [ Time Frame: during the single dose period and the first 21 days of multiple dosing (ie, by study day 29) ] [ Designated as safety issue: Yes ]
    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)

  • To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses [ 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. ] [ Designated as safety issue: No ]

    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

  • To obtain an preliminary assessment of the anti-tumour activity of AZD3514 [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD3514
Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351688

Locations
Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Glen Clack, MD AstraZeneca
Principal Investigator: Takefumi Sato, MD Kitasato University
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01351688     History of Changes
Other Study ID Numbers: D3760C00003
Study First Received: April 11, 2011
Last Updated: July 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase 1
Metastatic
Castration resistant
Prostate cancer
Androgen receptor
Down regulation
Japanese

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014