Status:
COMPLETED
Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 a...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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:
- 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
Key Trial Info
Start Date :
September 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02264418
Start Date
September 18 2014
End Date
May 1 2019
Last Update
January 18 2020
Active Locations (8)
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1
Finsen Centre
Copenhagen, Denmark
2
Helsinki University Central Hospital, Department of Oncology
Helsinki, Finland, 00029
3
Institut Bergonie
Bordeaux, France, 33000
4
Gustave Roussy Oncology Institute
Villejuif, France, 94805