Clinical trial NCT01351688: An Open Label Prostate Cancer Study in Japanese Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Phase 1
Metastatic
Castration resistant
Prostate cancer
Androgen receptor
Down regulation
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-11
Enrollment: 13
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer
timeFrame: 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
Secondary outcomes:
measure: To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514
timeFrame: during the single dose period and the first 21 days of multiple dosing (ie, by study day 29)
measure: To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses
timeFrame: 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.
measure: To obtain an preliminary assessment of the anti-tumour activity of AZD3514
timeFrame: Every 12 weeks
measure: To obtain an assessment of the activity of AZD3514 on the circulating levels of prostate-specific antigen (PSA)
timeFrame: Day 8, 15, 29 and every 4 weeks
Other outcomes:
Locations:
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Sunto-gun
country: Japan
facility: Research Site
state: Shizuoka
Study officials:
affiliation: AstraZeneca
name: Glen Clack, MD
role: STUDY_DIRECTOR
affiliation: Kitasato University
name: Takefumi Sato, MD
role: PRINCIPAL_INVESTIGATOR
References: