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An Open Label Prostate Cancer Study in Japanese Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351688
First Posted: May 11, 2011
Last Update Posted: July 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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) ]
    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. ]

    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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01351688     History of Changes
Other Study ID Numbers: D3760C00003
First Submitted: April 11, 2011
First Posted: May 11, 2011
Last Update Posted: July 3, 2013
Last Verified: July 2013

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