Prostate CancerPhase 1NCT01162395
Open Label Prostate Cancer Study
A Phase 1 study testing AZD3514 in people with Prostate Cancer, run by AstraZeneca at 5 sites in 3 countries.
Trial summary
The main purpose of the study is to investigate the safety and tolerability of AZD3514 when given orally to patients with castration-resistant prostate cancer (CRPC) Read more about this study
- Who is it for?
- Ages 20 to 130 years, 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
- 64 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2010to Oct 2015
- 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 to 130 years
- 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
- Presence of progressive disease defined as one or more:
- Biochemical progression of the prostate cancer
- Progression as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 guidelines
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- Two or more new metastatic bone lesions from bone scans from a previous assessment
- Serum testosterone concentration less or equals 50 ng/dL
- World Health Organization (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
- Sexually active males should be willing to use condoms
- For inclusion in the AZD3514 administered in combination with abiraterone acetate cohort(s), patients must:
- Have received prior chemotherapy containing or based on docetaxel
- Not have received prior treatment with abiraterone acetate, MDV3100, TAK700, TOK001 or other similar therapies which target the AR axis or with selective AR down-regulator-like properties
- For inclusion in the AZD3514 administered in combination with abiraterone acetate in patients who are currently receiving abiraterone acetate cohort(s), patients must:
- Have been stable on abiraterone acetate abiraterone acetate for ≥ 4 months (i.e. stable PSA values) and have achieved ≥ 50% reduction in PSA while being treated with abiraterone acetate
- Have evidence of biochemical progression (PSA) of the prostate cancer, as defined in inclusion number 5 (except for the withdrawal of abiraterone acetate as an anti-androgen therapy)
- For inclusion in the paired (same lesion) tumour biopsy research, patients must:
- Provide informed consent for paired tumour biopsy sampling
- Have bone or soft tissue lesions that are suitable for paired biopsy sampling
Who cannot join
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAEv4) grade 1 except for alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists
- Medically important spinal cord compression or brain metastases
- Medically important evidence of severe or uncontrolled systemic disease
- 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
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- Any medically important factors identified from electrocardiogram (ECG) measurements
- Concurrent or recent treatment with certain medications or medical procedures
- The following criteria exclude patients from entering the AZD3514 administered in combination with abiraterone acetate cohort(s):
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases or conditions, including adrenocortical insufficiency or a history of cardiovascular disease including heart failure (currently there are no randomized data for the use of abiraterone acetate in patients with LVEF < 50% or NYHA Class III or IV heart failure), which would make it undesirable for the patient to participate in the trial. See the full local prescribing information for abiraterone acetate for more detail
- Child-Pugh class B and C hepatic impairment
- If unable to fast for ≥ 2 hours prior to taking a dose to ≥ 1 hour post dose
- Received abiraterone acetate treatment previously
- Known hypersensitivity to components of prednisone or prednisolone
- Any systemic fungal infections
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
Research Site
Glasgow
Research Site
Manchester
Research Site
Surrey
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 Patients With Metastatic Castration-Resistant Prostate Cancer.
The main purpose of the study is to investigate the safety and tolerability of AZD3514 when given orally to patients with castration-resistant prostate cancer (CRPC)
- Conditions
- Prostate Cancer
- Being tested
- AZD3514
- Keywords
- Prostate Cancer, Tumour, Castration Resistant, Prostate Androgen Receptor Down Regulator, Metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Neoplasm Metastasis
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 orally as a single dose, and then multiple once daily dosing following a 5-9 day washout.
| Study group | Role | What they receive |
|---|---|---|
| A | 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 patients with CRPC.
Measured: At every visit.
Secondary outcomes (8)
To define the MTD, if possible, a lower biologically-effective dose(s) or maximum feasible dose (if decided by the Safety Review Committee (SRC) and AstraZeneca).
Measured: After each Cohort.
To characterise the PK of AZD3514 after a single oral dose and at steady state after multiple oral doses.
Measured: After each Cohort.
To obtain an assessment of the activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate on the circulating levels of prostate-specific antigen (PSA).
Measured: Visits 1, 4, 6, 7, 9, 10, follow-up visits, discontinuation visit
To obtain a preliminary assessment of the anti-tumour activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate by evaluation of counts of Circulating Tumour Cells (CTCs).
Measured: Visits 1, 6, 8, 9, 10, follow-up visits, discontinuation visit
To obtain an assessment of the activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate on the circulating levels of prostate-specific antigen (PSA).
Measured: Visits 1, 10, follow-up visits, discontinuation visit
To investigate safety, tolerability, MTD (and/or biologically-effective dose(s) or maximum feasible dose) and PK of AZD3514 and abiraterone when administered in combination, in patients who have not received prior treatment with abiraterone acetate
Measured: At every visit
To compare the PK of AZD3514 monotherapy in patients who have been fed or fasted before the administration of study treatment
Measured: At visits 2 and 4
To investigate the effect of AZD3514 on biomarkers of AR expression in paired pre- and post-dose tumour biopsies.
Measured: July 2012 - Feb 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2013
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Elliott, MD, Principal investigator, The Christie HospitalGlen Clack, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162395
- Sponsor's protocol ID
- D3760C00001
- Other IDs
- 2010-020232-19, IND 111707
- Status last verified
- Jan 2016
- First submitted
- 13 Jul 2010
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
James GD, Symeonides SN, Marshall J, Young J, Clack G. Continual reassessment method for dose escalation clinical trials in oncology: a comparison of prior skeleton approaches using AZD3514 data. BMC Cancer. 2016 Aug 31;16(1):703. doi: 10.1186/s12885-016-2702-6.
PubMed 27581751
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. 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 Patients With Metastatic Castration-Resistant Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01162395
- Acronym / sponsor ID
- D3760C00001
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Tumour, Castration Resistant, Prostate Androgen Receptor Down Regulator, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Jul 2010 (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 main purpose of the study is to investigate the safety and tolerability of AZD3514 when given orally to patients with castration-resistant prostate cancer (CRPC)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD3514Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD) |
Who may qualify
- Ages
- 20 to 130 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 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
- Presence of progressive disease defined as one or more:
- Biochemical progression of the prostate cancer
Key exclusion criteria (15 listed)
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAEv4) grade 1 except for alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists
- Medically important spinal cord compression or brain metastases
- Medically important evidence of severe or uncontrolled systemic disease
- 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
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 orally as a single dose, and then multiple once daily dosing following a 5-9 day washout. | Drug | A |
Primary outcome
To investigate the safety and tolerability of AZD3514 when given orally to patients with CRPC.
Time frame: At every visit.
8 secondary outcomes
To define the MTD, if possible, a lower biologically-effective dose(s) or maximum feasible dose (if decided by the Safety Review Committee (SRC) and AstraZeneca).
Time frame: After each Cohort.
To characterise the PK of AZD3514 after a single oral dose and at steady state after multiple oral doses.
Time frame: After each Cohort.
To obtain an assessment of the activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate on the circulating levels of prostate-specific antigen (PSA).
Time frame: Visits 1, 4, 6, 7, 9, 10, follow-up visits, discontinuation visit
To obtain a preliminary assessment of the anti-tumour activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate by evaluation of counts of Circulating Tumour Cells (CTCs).
Time frame: Visits 1, 6, 8, 9, 10, follow-up visits, discontinuation visit
To obtain an assessment of the activity of AZD3514 as monotherapy and/or in combination with abiraterone acetate on the circulating levels of prostate-specific antigen (PSA).
Time frame: Visits 1, 10, follow-up visits, discontinuation visit
To investigate safety, tolerability, MTD (and/or biologically-effective dose(s) or maximum feasible dose) and PK of AZD3514 and abiraterone when administered in combination, in patients who have not received prior treatment with abiraterone acetate
Time frame: At every visit
To compare the PK of AZD3514 monotherapy in patients who have been fed or fasted before the administration of study treatment
Time frame: At visits 2 and 4
To investigate the effect of AZD3514 on biomarkers of AR expression in paired pre- and post-dose tumour biopsies.
Time frame: July 2012 - Feb 2013
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 12 Jan 2016.
- Derived from this study: PubMed 27581751James GD, Symeonides SN, Marshall J, Young J, Clack G. Continual reassessment method for dose escalation clinical trials in oncology: a comparison of prior skeleton approaches using AZD3514 data. BMC Cancer. 2016 Aug 31;16(1):703. doi: 10.1186/s12885-016-2702-6.
- D3760C00001 Clinical Report SynopsisLink provided by the sponsor.
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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.
Tony Elliott, MD principal investigator
The Christie Hospital
Glen Clack, MD study director
AstraZeneca
5 sites in 3 countries: 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 5 sites in 3 countries.
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 19 inclusion and 15 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, United States, Netherlands. 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 patients with CRPC. (time frame: At every visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01162395, which also lists 1 linked publication.
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 12 Jan 2016.