Back to resultsAn Open Label Prostate Cancer Study in Japanese Patients
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
AZD3514
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Phase 1, Metastatic, Castration resistant, Prostate cancer, Androgen receptor, Down regulation, Japanese
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
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AZD3514
Arm Description
Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)
Outcomes
Primary Outcome Measures
To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer
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
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
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
To obtain an assessment of the activity of AZD3514 on the circulating levels of prostate-specific antigen (PSA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01351688
Brief Title
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
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Phase 1, Metastatic, Castration resistant, Prostate cancer, Androgen receptor, Down regulation, Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD3514
Arm Type
Experimental
Arm Description
Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)
Intervention Type
Drug
Intervention Name(s)
AZD3514
Intervention Description
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 Outcome Measure Information:
Title
To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer
Description
Number of participants with adverse events
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
Secondary Outcome Measure Information:
Title
To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514
Description
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)
Time Frame
during the single dose period and the first 21 days of multiple dosing (ie, by study day 29)
Title
To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses
Description
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
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.
Title
To obtain an preliminary assessment of the anti-tumour activity of AZD3514
Time Frame
Every 12 weeks
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen Clack, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Takefumi Sato, MD
Organizational Affiliation
Kitasato University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
An Open Label Prostate Cancer Study in Japanese Patients
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