Prostate CancerPhase 1ARAFORNCT01784757
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
A Phase 1 study testing ODM-201 Tablet A, ODM-201 Tablet B and ODM-201 capsule formulation in people with Prostate Cancer, run by Orion Corporation, Orion Pharma at 1 site in Latvia.
Trial summary
A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. 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?
- ODM-201 Tablet A, ODM-201 Tablet B and ODM-201 capsule formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLatvia
- Study dates
- Mar 2013to Dec 2020
- 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
- Written informed consent (IC) obtained.
- Histologically confirmed adenocarcinoma of prostate
- Progressive metastatic disease
- Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
- Adequate bone marrow, hepatic and renal function
- Able to swallow the ODM-201 whole as a capsule or tablet.
Who cannot join
- Previous chemotherapy for prostate cancer.
- Known metastases in the brain.
- History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
- Known gastrointestinal condition that can significantly affect the absorption of the study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
- Conditions
- Prostate Cancer
- Being tested
- ODM-201 Tablet A, ODM-201 Tablet B, ODM-201 capsule formulation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-201 Tablet ADrug
Tablet A formulation of ODM-201
ODM-201 Tablet BDrug
Tablet B formulation of ODM-201
ODM-201 capsule formulationDrug
Capsule formulation of ODM-201
| Study group | Role | What they receive |
|---|---|---|
| ODM-201 Tablet A | Experimental | ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order. Receives: Drug: ODM-201 Tablet A; Drug: ODM-201 capsule formulation |
| ODM-201 Tablet B | Experimental | ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order. Receives: Drug: ODM-201 Tablet B; Drug: ODM-201 capsule formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of ODM-201
The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
Measured: 0-48 hrs
Cmax of ODM-201
The plasma peak concentration.
Measured: 0-48 hrs
Secondary outcomes (3)
tmax of ODM-201
The time to reach peak concentration.
Measured: 0-48 hrs
Terminal elimination rate constant of ODM-201
The terminal elimination rate constant from log-linear portion of a concentration-time curve.
Measured: 0-48 hrs
Terminal elimination half-life of ODM-201
The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.
Measured: 0-48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionDec 2020
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Sponsor
- Investigators
- Karim Fizazi, MD PhD, Principal investigator, Institut Gustave Roussy, University of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784757
- Sponsor's protocol ID
- 3104003
- Other IDs
- 2012-002279-32
- Acronym
- ARAFOR
- Status last verified
- Mar 2021
- First submitted
- 4 Feb 2013
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.
PubMed 28753851
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01784757
- Acronym / sponsor ID
- ARAFOR / 3104003
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 6 Feb 2013 (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.
A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODM-201 Tablet A | Experimental | Drug: ODM-201 Tablet A, Drug: ODM-201 capsule formulationODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order. |
| ODM-201 Tablet B | Experimental | Drug: ODM-201 Tablet B, Drug: ODM-201 capsule formulationODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order. |
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)
- Written informed consent (IC) obtained.
- Histologically confirmed adenocarcinoma of prostate
- Progressive metastatic disease
- Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
- Adequate bone marrow, hepatic and renal function
Key exclusion criteria (4 listed)
- Previous chemotherapy for prostate cancer.
- Known metastases in the brain.
- History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
- Known gastrointestinal condition that can significantly affect the absorption of the study treatment.
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 |
|---|---|---|
| ODM-201 Tablet ATablet A formulation of ODM-201 | Drug | ODM-201 Tablet A |
| ODM-201 Tablet BTablet B formulation of ODM-201 | Drug | ODM-201 Tablet B |
| ODM-201 capsule formulationCapsule formulation of ODM-201 | Drug | ODM-201 Tablet A, ODM-201 Tablet B |
Primary outcome
Area under the curve (AUC) of ODM-201
Time frame: 0-48 hrs
The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
Cmax of ODM-201
Time frame: 0-48 hrs
The plasma peak concentration.
3 secondary outcomes
tmax of ODM-201
Time frame: 0-48 hrs
Terminal elimination rate constant of ODM-201
Time frame: 0-48 hrs
Terminal elimination half-life of ODM-201
Time frame: 0-48 hrs
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 17 Mar 2021.
- Derived from this study: PubMed 28753851Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.
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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.
Karim Fizazi, MD PhD principal investigator
Institut Gustave Roussy, University of Paris
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 ODM-201 Tablet A, ODM-201 Tablet B and ODM-201 capsule formulation in people with Prostate Cancer, run by Orion Corporation, Orion Pharma at 1 site in Latvia.
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 4 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 17 Mar 2021. 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 Latvia. 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?
Area under the curve (AUC) of ODM-201 (time frame: 0-48 hrs). The study lists 2 primary outcomes in all. 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 NCT01784757, 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 17 Mar 2021.