Prostate CancerPhase 1NCT01351688
An Open Label Prostate Cancer Study in Japanese Patients
A Phase 1 study testing AZD3514 in people with Prostate Cancer, run by AstraZeneca at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- AZD3514
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2011to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Research Site
Sagamihara, Kanagawa
Research Site
Sunto-gun, Shizuoka
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- AZD3514
- Keywords
- Phase 1, Metastatic, Castration resistant, Prostate cancer, Androgen receptor, Down regulation, Japanese
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis, Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3514Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| AZD3514 | Experimental | Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD) Receives: Drug: AZD3514 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (4)
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)
Measured: 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
Measured: 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 obtain an preliminary assessment of the anti-tumour activity of AZD3514
Measured: Every 12 weeks
To obtain an assessment of the activity of AZD3514 on the circulating levels of prostate-specific antigen (PSA)
Measured: Day 8, 15, 29 and every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen Clack, MD, Study director, AstraZenecaTakefumi Sato, MD, Principal investigator, Kitasato University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351688
- Sponsor's protocol ID
- D3760C00003
- Status last verified
- Jul 2013
- First submitted
- 11 Apr 2011
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01351688
- Acronym / sponsor ID
- D3760C00003
- Conditions
- Prostate Cancer
- Keywords
- Phase 1, Metastatic, Castration resistant, Prostate cancer, Androgen receptor, Down regulation, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD3514 | Experimental | Drug: AZD3514Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD) |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD3514Patients will be given AZD3514 tablets or capsules administered orally as a single dose, and then multiple once-daily dosing following a 7 day washout. | Drug | AZD3514 |
Primary outcome
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
4 secondary outcomes
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)
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Clack, MD study director
AstraZeneca
Takefumi Sato, MD principal investigator
Kitasato University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD3514 in people with Prostate Cancer, run by AstraZeneca at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.