Prostate CancerPhase 1SNACKNCT02883166
Improving Bio-availability of the Expensive Oral Oncolytic Drug Abiraterone by Food Intake
A Phase 1 study testing abiraterone in people with Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis. A pro-drug of abiraterone, abiraterone acetate (Zytiga®), was developed to overcome its poor bio-availability and is fully converted to the active moiety… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- abiraterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2016to Mar 2019
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
- Note: informed consent may be obtained prior to start of the specified screening window.
- Note: procedures conducted as part of the subject's routine clinical management (e.g. blood count) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
- ≥ 18 year old men who use or will start with abiraterone.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Feasible to collect blood samples from.
Who cannot join
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- Malabsorption syndrome.
- Major resection of the stomach or small bowel.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- Unable or unwilling to discontinue use of prohibited medications listed in APPENDIX 3 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of day 1 and for the duration of the study.
- Concurrent use of other substances known or likely to interfere with the pharmacokinetics of abiraterone.
Trial locations and contacts
1 site in 1 country.
About this study
Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis. A pro-drug of abiraterone, abiraterone acetate (Zytiga®), was developed to overcome its poor bio-availability and is fully converted to the active moiety abiraterone. Abiraterone acetate tablets are administered at a fixed oral dose of 1000mg QD in a fasted state in combination with 10mg prednisolon daily.
Abiraterone acetate has a low solubility in aqueous media and a low permeability. The bioavailability of abiraterone acetate is significantly influenced when ingested with food. Ingesting abiraterone acetate with a low fat or a high fat meal resulted respectively in a 5- or 10-fold increase in AUC0-∞. The high and low fat FDA meals used in these food effect studies differ largely from breakfasts taken in everyday life (ca. 800-1000 cal). A continental breakfast contains 160 to 320 calories of which 25-50% is fat, is more compatible with a normal lifestyle and therefore easily sustainable in daily practice. However, the effect of a continental breakfast on the absorption of abiraterone is unknown yet. Furthermore, increasing healthcare costs are a growing concern in all developed countries. Therefore effort should be invested to keep anticancer treatment affordable. A food intervention resulting in a better absorption and enhanced exposure to abiraterone, can lead to a reduced dose, which could significantly impact health care costs for a tumor which is as prevalent as metastatic prostate cancer.
Therefore the investigators want to perform a bioequivalent study to investigate what dose of abiraterone with a continental breakfast equals the dose of 1000mg taken in fasted conditions.
- Conditions
- Prostate Cancer
- Being tested
- abiraterone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abirateroneDrug
Also called Zytiga
integested with a continental breakfast
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | 1000mg abiraterone fasted followed by 500 mg with breakfast Receives: Drug: abiraterone |
| group 2 | Other | 500 mg abiraterone with breakfast followed by 1000mg fasted Receives: Drug: abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose finding
determine the equivalent dose of abiraterone when taken with a continental breakfast compared to 1000mg in fasted state
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2019
- Study completionMar 2019
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 Radboud University Medical CenterThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Burger, PhD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883166
- Sponsor's protocol ID
- UMCN-AKF-16.04
- Acronym
- SNACK
- Status last verified
- Dec 2020
- First submitted
- 25 Aug 2016
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lubberman FJE, Benoist GE, Gerritsen W, Burger DM, Mehra N, Hamberg P, van Oort I, van Erp NP. A prospective phase I multicentre randomized cross-over pharmacokinetic study to determine the effect of food on abiraterone pharmacokinetics. Cancer Chemother Pharmacol. 2019 Dec;84(6):1179-1185. doi: 10.1007/s00280-019-03952-w. Epub 2019 Sep 12.
PubMed 31515667
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Bio-availability of the Expensive Oral Oncolytic Drug Abiraterone by Food Intake
- ClinicalTrials.gov ID
- NCT02883166
- Acronym / sponsor ID
- SNACK / UMCN-AKF-16.04
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 30 Aug 2016 (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.
Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis. A pro-drug of abiraterone, abiraterone acetate (Zytiga®), was developed to overcome its poor bio-availability and is fully converted to the active moiety abiraterone. Abiraterone acetate tablets are administered at a fixed oral dose of 1000mg QD in a fasted state in combination with 10mg prednisolon daily.
Abiraterone acetate has a low solubility in aqueous media and a low permeability. The bioavailability of abiraterone acetate is significantly influenced when ingested with food. Ingesting abiraterone acetate with a low fat or a high fat meal resulted respectively in a 5- or 10-fold increase in AUC0-∞. The high and low fat FDA meals used in these food effect studies differ largely from breakfasts taken in everyday life (ca. 800-1000 cal). A continental breakfast contains 160 to 320 calories of which 25-50% is fat, is more compatible with a normal lifestyle and therefore easily sustainable in daily practice. However, the effect of a continental breakfast on the absorption of abiraterone is unknown yet. Furthermore, increasing healthcare costs are a growing concern in all developed countries. Therefore effort should be invested to keep anticancer treatment affordable. A food intervention resulting in a better absorption and enhanced exposure to abiraterone, can lead to a reduced dose, which could significantly impact health care costs for a tumor which is as prevalent as metastatic prostate cancer.
Therefore the investigators want to perform a bioequivalent study to investigate what dose of abiraterone with a continental breakfast equals the dose of 1000mg taken in fasted conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Drug: abiraterone1000mg abiraterone fasted followed by 500 mg with breakfast |
| group 2 | Other | Drug: abiraterone500 mg abiraterone with breakfast followed by 1000mg fasted |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
- Note: informed consent may be obtained prior to start of the specified screening window.
- Note: procedures conducted as part of the subject's routine clinical management (e.g. blood count) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
- ≥ 18 year old men who use or will start with abiraterone.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (6 listed)
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- Malabsorption syndrome.
- Major resection of the stomach or small bowel.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- Unable or unwilling to discontinue use of prohibited medications listed in APPENDIX 3 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of day 1 and for the duration of the study.
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 |
|---|---|---|
| abirateroneAlso: Zytigaintegested with a continental breakfast | Drug | group 1, group 2 |
Primary outcome
dose finding
Time frame: 1.5 year
determine the equivalent dose of abiraterone when taken with a continental breakfast compared to 1000mg in fasted state
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 7 Dec 2020.
- Background: PubMed 31515667Lubberman FJE, Benoist GE, Gerritsen W, Burger DM, Mehra N, Hamberg P, van Oort I, van Erp NP. A prospective phase I multicentre randomized cross-over pharmacokinetic study to determine the effect of food on abiraterone pharmacokinetics. Cancer Chemother Pharmacol. 2019 Dec;84(6):1179-1185. doi: 10.1007/s00280-019-03952-w. Epub 2019 Sep 12.
- paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David Burger, PhD study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing abiraterone in people with Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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 6 inclusion and 6 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 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
dose finding (time frame: 1.5 year). 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 NCT02883166, 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 7 Dec 2020.