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NCT Number: NCT01351688

An Open Label Prostate Cancer Study in Japanese Patients

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.

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Key information

Conditions

Prostate Cancer Bulbo-Spinal Atrophy, X-Linked Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Heredodegenerative Disorders, Nervous System Male Urogenital Diseases Motor Neuron Disease Muscular Atrophy, Spinal Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Spinal Cord Diseases Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Sagamihara, Kanagawa, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3514

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.

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. To obtain an preliminary assessment of the anti-tumour activity of AZD3514

    Time frame: Every 12 weeks

  4. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 11, 2011
Registry last updated
Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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