Prostate CancerPhase 1/2DUALIDESNCT02344017
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1/2 study testing ODM-204 and Prednisone in people with Prostate Cancer, run by Orion Corporation, Orion Pharma at 4 sites in 4 countries.
Trial summary
The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 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
- What is being tested?
- ODM-204 and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2015to Jan 2019
- Phase
- Phase 1/2
- 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.
- Male aged ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
- Progressive metastatic disease
- Adequate bone marrow, hepatic, and renal function
- Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment
- Ability to swallow study treatments
Who cannot join
- History of pituitary or adrenal dysfunction.
- Known brain metastases.
- Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
- Uncontrolled hypertension
- Clinically significant heart disease
- Prolonged QTc interval
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion
The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.
Read the detailed description
The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.
- Conditions
- Prostate Cancer
- Being tested
- ODM-204, Prednisone
- 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-204Drug
co-administered with prednisone, orally daily
PrednisoneDrug
ODM-204 is co-administered with oral prednisone
| Study group | Role | What they receive |
|---|---|---|
| ODM-204 Phase I dose escalation | Experimental | Dose escalation Receives: Drug: ODM-204; Drug: Prednisone |
| ODM-204 Phase II dose expansion | Experimental | Not described Receives: Drug: ODM-204; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed by incidence of adverse events
Measured: Until disease progression, an expected average of 6 months
Safety and tolerability assessed by vitals signs and 12-lead ECG
Measured: Until disease progression, an expected average of 6 months
Safety and tolerability assessed by laboratory assessments
Measured: Until disease progression, an expected average of 6 months
Secondary outcomes (6)
Pharmacokinetic profile assessed by plasma peak concentration (Cmax)
Measured: 0 - week 12
Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)
Measured: 0 - week 12
Pharmacokinetic profile assessed by time to reach peak concentration (tmax)
Measured: 0 - week 12
Preliminary antitumour activity assessed by prostate specific antigen (PSA) response
Measured: Until disease progression, an expected average of 6 months
Preliminary antitumour activity assessed by response in soft and bone tissues
Measured: Until disease progression, an expected average of 6 months
Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements
Measured: 0 - week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2019
- Study completionJan 2019
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.
- 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
- 23 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
- NCT02344017
- Sponsor's protocol ID
- 3116001
- Acronym
- DUALIDES
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2014
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion
- ClinicalTrials.gov ID
- NCT02344017
- Acronym / sponsor ID
- DUALIDES / 3116001
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 22 Jan 2015 (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 purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.
Detailed description
The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODM-204 Phase I dose escalation | Experimental | Drug: ODM-204, Drug: PrednisoneDose escalation |
| ODM-204 Phase II dose expansion | Experimental | Drug: ODM-204, Drug: Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent (IC) obtained.
- Male aged ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
- Progressive metastatic disease
Key exclusion criteria (6 listed)
- History of pituitary or adrenal dysfunction.
- Known brain metastases.
- Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
- Uncontrolled hypertension
- Clinically significant heart disease
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-204co-administered with prednisone, orally daily | Drug | ODM-204 Phase I dose escalation, ODM-204 Phase II dose expansion |
| PrednisoneODM-204 is co-administered with oral prednisone | Drug | ODM-204 Phase I dose escalation, ODM-204 Phase II dose expansion |
Primary outcome
Safety and tolerability assessed by incidence of adverse events
Time frame: Until disease progression, an expected average of 6 months
Safety and tolerability assessed by vitals signs and 12-lead ECG
Time frame: Until disease progression, an expected average of 6 months
Safety and tolerability assessed by laboratory assessments
Time frame: Until disease progression, an expected average of 6 months
6 secondary outcomes
Pharmacokinetic profile assessed by plasma peak concentration (Cmax)
Time frame: 0 - week 12
Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)
Time frame: 0 - week 12
Pharmacokinetic profile assessed by time to reach peak concentration (tmax)
Time frame: 0 - week 12
Preliminary antitumour activity assessed by prostate specific antigen (PSA) response
Time frame: Until disease progression, an expected average of 6 months
Preliminary antitumour activity assessed by response in soft and bone tissues
Time frame: Until disease progression, an expected average of 6 months
Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements
Time frame: 0 - week 12
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 19 Dec 2019.
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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
4 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-204 and Prednisone in people with Prostate Cancer, run by Orion Corporation, Orion Pharma at 4 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?
The sponsor lists 8 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 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, France, Latvia, United Kingdom. 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?
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?
Safety and tolerability assessed by incidence of adverse events (time frame: Until disease progression, an expected average of 6 months). The study lists 3 primary outcomes in all. 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 19 Dec 2019.