Solid TumoursPhase 1KIDES-203NCT02264418
Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours
A Phase 1 study testing ODM 203 in people with Solid Tumours, run by Orion Corporation, Orion Pharma at 8 sites in 6 countries.
Trial summary
The purpose of this first-in-human study is to evaluate the safety and tolerability of escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the maximum tolerated dose and dose limiting toxicities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- ODM 203
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 18 Sep 2014to May 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male and female subjects over 18 years of age
- Subjects with histologically or cytologically confirmed locally advanced or metastatic tumours. Subjects in Part 2 to have a tumour/genetic aberration.
- Availability of tumour sample for genetic analysis
- Adequate haemopoietic, hepatic and renal function
- Eastern Cooperative Oncology Group performance status of 0 to 1
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- Serum mineral levels phosphate: 2.5 mg/dl; calcium: 8.8 mg/dl; magnesium: 1.2 mg/dl; potassium: 11.7 mg/dl; sodium: 299mg/dl.
- Recovery from reversible adverse events of previous systemic anti-cancer therapies to baseline or grade 1 with the exception of alopecia;stable neuropathy of grade 2 induced by previous cancer treatment
- Life expectancy of 12 weeks or more
Who cannot join
- Any prior anti VEGFR/FGFR treatment related AE that in the judgement of the investigator is considered severe/life threatening
- Subjects receiving warfarin
- Active central nervous system metastases not controlled by prior surgery/radiotherapy and/or low dose steroids for 4 weeks or more
- Subjects with current evidence of endocrine alteration of calcium-phosphate homeostasis
- Concomitant therapies known to increase serum phosphorus and/or calcium levels that cannot be discontinued or switched to a different therapy are not permitted within 14 days before the first dose of ODM-203.
- Significant cardiovascular conditions/circumstances as follows:
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- a active or unstable cardio/cerebro-vascular disease
- b Uncontrolled hypertension (systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 90mg Hg with optimised antihypertensive therapy.
- c history of severe arrhythmia, familial arrhythmia, conduction abnormality or congenital long QT syndrome
- dConcomitant therapies known to prolong the QT interval and associated with a risk of Torsades de Pointes are not permitted within 7 days before the first dose of ODM 203
- e Repeatable prolongation of QTcF interval ≥ 450 msec or any clinically significant abnormality in the ECG at screening in 2 out of 3 recordings
- f Left ventricular ejection fraction <50% at screening
- Subjects who received systemic anticancer treatment prior to the first dose of ODM-203 within the following timeframes: less than 28 days since the last dose of antineoplastic therapy and/or 28 days of wide field radiotherapy or 14 days of limited field radiation for palliation
- Major surgery or serious infection within 21 days of the first dose of ODM-203
- Known gastrointestinal disease or a procedure that may affect absorption of ODM 203
- Serious concurrent medical condition or psychiatric illness
- History and/or current evidence of ectopic mineralisation/calcification
- Known active or past history of other primary malignancy
- Female of child bearing potential
- Female of child bearing potential or male subject with a female partner of child bearing potential who does not agree to use effective contraception during the study and for 3 months after the last dose of ODM 203
- Known hypersensitivity to the study treatment excipients
- Any condition which in the opinion of the investigator would impair the subject's ability to comply with the study procedures
- Participation in another interventional clinical trial/ concurrent treatment with any investigational drug within 4 weeks prior to the start of treatment with ODM 203
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
France2 sites
Institut Bergonie
Bordeaux, 33000
Gustave Roussy Oncology Institute
Villejuif, 94805
United Kingdom2 sites
Sarah cannon Research Institute
London, W1G6AD
UCL Cancer Institute
London, WC1E6DD
Finland1 site
Helsinki University Central Hospital, Department of Oncology
Helsinki, 00029
About this study
Official title: Safety and Tolerability of Single and Repeated Doses of ODM-203: An Open-label, Non-randomised, Uncontrolled, Dose Escalation, Multicentre, First-in-Human Study in Subjects With Advanced Solid Tumours
The purpose of this first-in-human study is to evaluate the safety and tolerability of escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the maximum tolerated dose and dose limiting toxicities.
Read the detailed description
The safety profile of ODM-203 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-203 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM 203 will be evaluated after single and multiple dose administrations at different dose levels
- Conditions
- Solid Tumours
- Being tested
- ODM 203
- Keywords
- Solid tumours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM 203Drug
ODM 203
ODM 203Drug
ODM 203
| Study group | Role | What they receive |
|---|---|---|
| ODM 203 | Experimental | Oral capsules given once daily dosage 50-800mg Receives: Drug: ODM 203 |
| ODM-203 | Experimental | Oral tablets given once daily 200-1600mg Receives: Drug: ODM 203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of adverse event counts
Measured: From the date of informed consent to the date of the end of study visit estimated to be 6 months
Secondary outcomes (4)
Frequency of responders to Response evaluation criteria in solid tumours (RECIST)
The frequency of responders according to RECIST will be evaluated by dose level.
Measured: Subjects will be followed for the duration of time in the study, expected to be an average of 6 months
Eastern Cooperative Oncology Group (ECOG) Performance status
The ECOG performance status and the change from baseline will be reported by dose level.
Measured: Subjects will be followed for the duration of time in the study, expected to be an average of 6 months
Area under the plasma concentration curve (AUC)
Area under the plasma concentration curve (AUC) of ODM-203 will be measured to evaluate the relationship between ODM-203 dose, plasma exposure, pharmacodynamics and safety
Measured: 0 to 24hours post dose Day 1 and Day 15
Peak plasma concentration (Cmax)
Peak plasma concentration (Cmax) of ODM-203 will be measured to evaluate the relationship between ODM-203 dose, plasma exposure, pharmacodynamics and safety
Measured: After first dose administration to 24 hours Day 1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study start18 Sep 2014
- Primary completionMay 2019
- Study completionMay 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 TumoursStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petri Bono, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264418
- Sponsor's protocol ID
- 3113001
- Acronym
- KIDES-203
- Status last verified
- Jan 2020
- First submitted
- 19 Sep 2014
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bono P, Massard C, Peltola KJ, Azaro A, Italiano A, Kristeleit RS, Curigliano G, Lassen U, Arkenau HT, Hakulinen P, Garratt C, Ikonen T, Mustonen MVJ, Rodon JA. Phase I/IIa, open-label, multicentre study to evaluate the optimal dosing and safety of ODM-203 in patients with advanced or metastatic solid tumours. ESMO Open. 2020 Dec;5(6):e001081. doi: 10.1136/esmoopen-2020-001081.
PubMed 33262202
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Single and Repeated Doses of ODM-203: An Open-label, Non-randomised, Uncontrolled, Dose Escalation, Multicentre, First-in-Human Study in Subjects With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT02264418
- Acronym / sponsor ID
- KIDES-203 / 3113001
- Conditions
- Solid Tumours
- Keywords
- Solid tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2014 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 15 Oct 2014 (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-human study is to evaluate the safety and tolerability of escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the maximum tolerated dose and dose limiting toxicities.
Detailed description
The safety profile of ODM-203 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-203 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM 203 will be evaluated after single and multiple dose administrations at different dose levels
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODM 203 | Experimental | Drug: ODM 203Oral capsules given once daily dosage 50-800mg |
| ODM-203 | Experimental | Drug: ODM 203Oral tablets given once daily 200-1600mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Male and female subjects over 18 years of age
- Subjects with histologically or cytologically confirmed locally advanced or metastatic tumours. Subjects in Part 2 to have a tumour/genetic aberration.
- Availability of tumour sample for genetic analysis
- Adequate haemopoietic, hepatic and renal function
Key exclusion criteria (23 listed)
- Any prior anti VEGFR/FGFR treatment related AE that in the judgement of the investigator is considered severe/life threatening
- Subjects receiving warfarin
- Active central nervous system metastases not controlled by prior surgery/radiotherapy and/or low dose steroids for 4 weeks or more
- Subjects with current evidence of endocrine alteration of calcium-phosphate homeostasis
- Concomitant therapies known to increase serum phosphorus and/or calcium levels that cannot be discontinued or switched to a different therapy are not permitted within 14 days before the first dose of ODM-203.
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 203ODM 203 | Drug | ODM 203 |
| ODM 203ODM 203 | Drug | ODM 203, ODM-203 |
Primary outcome
Number of adverse events
Time frame: From the date of informed consent to the date of the end of study visit estimated to be 6 months
Number of adverse event counts
4 secondary outcomes
Frequency of responders to Response evaluation criteria in solid tumours (RECIST)
Time frame: Subjects will be followed for the duration of time in the study, expected to be an average of 6 months
Eastern Cooperative Oncology Group (ECOG) Performance status
Time frame: Subjects will be followed for the duration of time in the study, expected to be an average of 6 months
Area under the plasma concentration curve (AUC)
Time frame: 0 to 24hours post dose Day 1 and Day 15
Peak plasma concentration (Cmax)
Time frame: After first dose administration to 24 hours Day 1 and Day 15
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 18 Jan 2020.
- Derived from this study: PubMed 33262202Bono P, Massard C, Peltola KJ, Azaro A, Italiano A, Kristeleit RS, Curigliano G, Lassen U, Arkenau HT, Hakulinen P, Garratt C, Ikonen T, Mustonen MVJ, Rodon JA. Phase I/IIa, open-label, multicentre study to evaluate the optimal dosing and safety of ODM-203 in patients with advanced or metastatic solid tumours. ESMO Open. 2020 Dec;5(6):e001081. doi: 10.1136/esmoopen-2020-001081.
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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.
Petri Bono, MD principal investigator
Helsinki University Central Hospital
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ODM 203 in people with Solid Tumours, run by Orion Corporation, Orion Pharma at 8 sites in 6 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 9 inclusion and 23 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, United Kingdom, Denmark, Finland, Italy and 1 more country. 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?
Number of adverse events (time frame: From the date of informed consent to the date of the end of study visit estimated to be 6 months). 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 NCT02264418, 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 18 Jan 2020.