Prostate Cancer MetastaticPhase 1/2STESIDESNCT03878823
Safety and Pharmacokinetics of ODM-209
A Phase 1/2 study testing ODM-209 in people with Prostate Cancer Metastatic and Advanced Breast Cancer, run by Orion Corporation, Orion Pharma at 4 sites in 3 countries.
Trial summary
The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer
- What is being tested?
- ODM-209
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 17 Apr 2019to 9 Jan 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
MAIN INCLUSION CRITERIA:
- Written informed consent (IC) obtained.
- Age ≥ 18 years.
- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- Able to swallow study treatment.
Main Prostate cancer specific inclusion criteria:
- 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 have had bilateral orchiectomy.
- Have had treatment with at least one line of second generation androgen receptor targeting therapy and one line of chemotherapy.
Main Breast cancer specific inclusion criteria:
- Histologically confirmed breast carcinoma
- ER positive, HER2-negative advanced breast cancer
- Postmenopausal or pre/perimenopausal if amendable to be treated with GnRH agonist or antagonist.
- Documented disease progression after treatment with at least 2 lines of systemic treatment for advanced breast cancer. Of these, at least one line must have been endocrine treatment in combination with a cdk4/6 inhibitor.
MAIN EXCLUSION CRITERIA
- History of pituitary dysfunction.
- Known brain metastases or active leptomeningeal disease.
- Active infection or other medical condition that would make corticosteroids contraindicated.
- Hypotension or uncontrolled hypertension.
- Clinically significant cardiovascular disease, e.g. myocardial infarction, arterial thrombotic events, or pulmonary embolism in the past six months, unstable angina, or congestive heart failure (New York Heart Association [NYHA] class II-IV).
- Prolonged QTcF interval.
- Use of any investigational drug 4 weeks prior to the start of the study treatment.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Finland2 sites
Helsinki University Central Hospital
Helsinki
Tampere University Hospital
Tampere
About this study
Official title: Safety and Pharmacokinetics of ODM-209 in Patients With Metastatic Castration-resistant Prostate Cancer or Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer
The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
Read the detailed description
Part 1: to evaluate the safety and tolerability of ODM-209, to define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ODM-209, if feasible, to define the recommended dose of ODM-209 and replacement therapy for Part 2 of the study.
Part 2: to further evaluate the safety and tolerability of ODM-209, to evaluate the preliminary anticancer activity of ODM-209.
- Conditions
- Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer, Metastatic Breast Cancer
- Being tested
- ODM-209
- Keywords
- metastatic castration-resistant prostate cancer, advanced hormone receptor positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-209Drug
co-administered with glucocorticoid and mineralocorticoid, orally daily
| Study group | Role | What they receive |
|---|---|---|
| ODM-209 Part 1 Dose escalation | Experimental | Not described Receives: Drug: ODM-209 |
| ODM-209 Part 2 Dose expansion | Experimental | Not described Receives: Drug: ODM-209 |
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 posted18 Mar 2019
- Study start17 Apr 2019
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jutta Hänninen, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878823
- Sponsor's protocol ID
- 3125001
- Acronym
- STESIDES
- Status last verified
- Jan 2024
- First submitted
- 15 Mar 2019
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of ODM-209 in Patients With Metastatic Castration-resistant Prostate Cancer or Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03878823
- Acronym / sponsor ID
- STESIDES / 3125001
- Conditions
- Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer, Metastatic Breast Cancer
- Keywords
- metastatic castration-resistant prostate cancer, advanced hormone receptor positive breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 18 Mar 2019 (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-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
Detailed description
Part 1: to evaluate the safety and tolerability of ODM-209, to define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ODM-209, if feasible, to define the recommended dose of ODM-209 and replacement therapy for Part 2 of the study.
Part 2: to further evaluate the safety and tolerability of ODM-209, to evaluate the preliminary anticancer activity of ODM-209.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODM-209 Part 1 Dose escalation | Experimental | Drug: ODM-209 |
| ODM-209 Part 2 Dose expansion | Experimental | Drug: ODM-209 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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-209co-administered with glucocorticoid and mineralocorticoid, orally daily | Drug | ODM-209 Part 1 Dose escalation, ODM-209 Part 2 Dose expansion |
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
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 1 Feb 2024.
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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.
Jutta Hänninen study director
Orion Corporation, Orion Pharma
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ODM-209 in people with Prostate Cancer Metastatic and Advanced Breast Cancer, run by Orion Corporation, Orion Pharma at 4 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?
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 1 Feb 2024. 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, Denmark, France. 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?
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?
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 1 Feb 2024.