Prostate Cancer MetastaticPhase 1/2CYPIDESNCT03436485
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 1/2 study testing ODM-208 and Midazolam in people with Prostate Cancer Metastatic, run by Orion Corporation, Orion Pharma at 20 sites in 4 countries.
Trial summary
The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic 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 Metastatic
- What is being tested?
- ODM-208 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 19 Mar 2018to 31 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
Main Inclusion Criteria:
- Written informed consent (IC) obtained.
- Male aged ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Castration resistant prostate cancer with serum testosterone < 50 ng/dl.
- Metastatic disease.
- Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
- Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide).
- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- Able to swallow study treatment.
- Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC.
Main Exclusion Criteria:
- History of pituitary or adrenal dysfunction.
- Known brain metastases or active leptomeningeal disease.
- Active infection or other medical condition that would make corticosteroid contraindicated.
- Poorly controlled diabetes.
- Hypotension or uncontrolled hypertension.
- Clinically significantly abnormal serum potassium or sodium level.
- Active or unstable cardio/cerebro-vascular disease including thromboembolic events.
- Prolonged QTcF interval.
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United Kingdom8 sites
The Rutherford Cancer Centre, North East
Bedlington
Velindre Cancer Centre
Cardiff, CF14 2TL
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
The Rutherford Cancer Centre, North West
Liverpool
Royal Marsden Hospital
London, SW3 6JJ
Charing Cross Hospital
London
The Christie NHS Foundation Trust
Manchester
Royal Preston Hospital
Preston, PR2 9HT
France6 sites
Institute Bergonié
Bordeaux
Centre Léon Bérard
Lyon
Institute Paoli-Calmettes
Marseille
Institut de cancérologie Strasbourg Europe
Strasbourg
Hopital Foch
Suresnes, 92150
Institut Gustave Roussy
Villejuif
United States4 sites
University of Maryland Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201
University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative
Buffalo, New York, 14203
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Nebraska Cancer Specialists
Omaha, Nebraska, 68114
Finland2 sites
Helsinki University Central Hospital
Helsinki
Tampere University Hospital
Tampere
About this study
The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.
Read the detailed description
Safety and tolerability profile of ODM-208 will be explored
- Conditions
- Prostate Cancer Metastatic
- Being tested
- ODM-208, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-208Drug
co-administered with glucocorticoid and fludrocortisone, orally daily
MidazolamDrug
orally
| Study group | Role | What they receive |
|---|---|---|
| ODM-208 Part 1 Dose escalation | Experimental | Not described Receives: Drug: ODM-208 |
| ODM-208 Part 2 Dose expansion | Experimental | Not described Receives: Drug: ODM-208 |
| ODM-208 Part 2 Drug drug interaction | Experimental | Not described Receives: Drug: ODM-208; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Highest dose level at which under 33% of patients in a cohort experience DLT
Measured: Within first 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start19 Mar 2018
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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 Cancer MetastaticStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karim Fizazi, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436485
- Sponsor's protocol ID
- 3124001
- Acronym
- CYPIDES
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2018
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fizazi K, Bernard-Tessier A, Roubaud G, Utriainen T, Barthelemy P, Flechon A, van der Voet J, Gravis G, Ratta R, Jones R, Parikh O, Tanner M, Antonarakis ES, Baldini C, Peters N, Garratt C, Ikonen T, Pohjanjousi P, Joensuu H, Cook N. Targeted Inhibition of CYP11A1 in Castration-Resistant Prostate Cancer. NEJM Evid. 2024 Jan;3(1):EVIDoa2300171. doi: 10.1056/EVIDoa2300171. Epub 2023 Dec 26.
PubMed 38320513
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03436485
- Acronym / sponsor ID
- CYPIDES / 3124001
- Conditions
- Prostate Cancer Metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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 purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.
Detailed description
Safety and tolerability profile of ODM-208 will be explored
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ODM-208 Part 1 Dose escalation | Experimental | Drug: ODM-208 |
| ODM-208 Part 2 Dose expansion | Experimental | Drug: ODM-208 |
| ODM-208 Part 2 Drug drug interaction | Experimental | Drug: ODM-208, Drug: Midazolam |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-208co-administered with glucocorticoid and fludrocortisone, orally daily | Drug | ODM-208 Part 1 Dose escalation, ODM-208 Part 2 Dose expansion, ODM-208 Part 2 Drug drug interaction |
| Midazolamorally | Drug | ODM-208 Part 2 Drug drug interaction |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Within first 28 days of treatment
Highest dose level at which under 33% of patients in a cohort experience DLT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 38320513Fizazi K, Bernard-Tessier A, Roubaud G, Utriainen T, Barthelemy P, Flechon A, van der Voet J, Gravis G, Ratta R, Jones R, Parikh O, Tanner M, Antonarakis ES, Baldini C, Peters N, Garratt C, Ikonen T, Pohjanjousi P, Joensuu H, Cook N. Targeted Inhibition of CYP11A1 in Castration-Resistant Prostate Cancer. NEJM Evid. 2024 Jan;3(1):EVIDoa2300171. doi: 10.1056/EVIDoa2300171. Epub 2023 Dec 26.
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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 principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ODM-208 and Midazolam in people with Prostate Cancer Metastatic, run by Orion Corporation, Orion Pharma at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom, France, United States, Finland. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Maximum tolerated dose (MTD) (time frame: Within first 28 days of treatment). 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 NCT03436485, 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 14 Aug 2026.