Solid TumorsPhase 1/2BETIDESNCT03035591
ODM-207 in Patients With Advance Solid Tumours
A Phase 1/2 study testing ODM-207 in people with Solid Tumors, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ODM-207
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFinland
- Study dates
- 22 Dec 2016to 10 May 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy
- Life expectancy >12 weeks
- Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression
- ECOG performance status of 0 to 1
Who cannot join
- History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment
- Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)
- History of or current leptomeningeal or brain metastasis or spinal cord compression.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Department of Oncology
Helsinki, 00029
About this study
Official title: Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion
This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.
- Conditions
- Solid Tumors
- Being tested
- ODM-207
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-207Drug
| Study group | Role | What they receive |
|---|---|---|
| ODM-207 | Experimental | Escalating doses of ODM-207 Receives: Drug: ODM-207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (DLT)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start22 Dec 2016
- Primary completion10 May 2019
- Study completion10 May 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 Solid TumorsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johann De Bono, Principal investigator, ICR/Royal Marsden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035591
- Sponsor's protocol ID
- 3121001
- Acronym
- BETIDES
- Status last verified
- Oct 2019
- First submitted
- 20 Jan 2017
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ameratunga M, Brana I, Bono P, Postel-Vinay S, Plummer R, Aspegren J, Korjamo T, Snapir A, de Bono JS. First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours. Br J Cancer. 2020 Dec;123(12):1730-1736. doi: 10.1038/s41416-020-01077-z. Epub 2020 Sep 29.
PubMed 32989226
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion
- ClinicalTrials.gov ID
- NCT03035591
- Acronym / sponsor ID
- BETIDES / 3121001
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 30 Jan 2017 (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.
This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODM-207 | Experimental | Drug: ODM-207Escalating doses of ODM-207 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy
- Life expectancy >12 weeks
- Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression
- ECOG performance status of 0 to 1
Key exclusion criteria (3 listed)
- History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment
- Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)
- History of or current leptomeningeal or brain metastasis or spinal cord compression.
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-207 | Drug | ODM-207 |
Primary outcome
Maximum Tolerated Dose
Time frame: 28 days
Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (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 15 Oct 2019.
- Derived from this study: PubMed 32989226Ameratunga M, Brana I, Bono P, Postel-Vinay S, Plummer R, Aspegren J, Korjamo T, Snapir A, de Bono JS. First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours. Br J Cancer. 2020 Dec;123(12):1730-1736. doi: 10.1038/s41416-020-01077-z. Epub 2020 Sep 29.
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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.
Johann De Bono principal investigator
ICR/Royal Marsden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ODM-207 in people with Solid Tumors, run by Orion Corporation, Orion Pharma at 1 site in Finland.
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 4 inclusion and 3 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 15 Oct 2019. 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 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?
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 (time frame: 28 days). 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 NCT03035591, 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 15 Oct 2019.