Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-03 @ 6:46 PM
Study NCT ID:
NCT02264418
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2014-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'From the date of informed consent to the date of the end of study visit estimated to be 6 months', 'description': 'Number of adverse event counts'}], 'secondaryOutcomes': [{'measure': 'Frequency of responders to Response evaluation criteria in solid tumours (RECIST)', 'timeFrame': 'Subjects will be followed for the duration of time in the study, expected to be an average of 6 months', 'description': 'The frequency of responders according to RECIST will be evaluated by dose level.'}, {'measure': 'Eastern Cooperative Oncology Group (ECOG) Performance status', 'timeFrame': 'Subjects will be followed for the duration of time in the study, expected to be an average of 6 months', 'description': 'The ECOG performance status and the change from baseline will be reported by dose level.'}, {'measure': 'Area under the plasma concentration curve (AUC)', 'timeFrame': '0 to 24hours post dose Day 1 and Day 15', 'description': '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'}, {'measure': 'Peak plasma concentration (Cmax)', 'timeFrame': 'After first dose administration to 24 hours Day 1 and Day 15', 'description': 'Peak plasma concentration (Cmax) of ODM-203 will be measured to evaluate the relationship between ODM-203 dose, plasma exposure, pharmacodynamics and safety'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Solid tumours'], 'conditions': ['Solid Tumours']}, 'referencesModule': {'references': [{'pmid': '33262202', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* Male and female subjects over 18 years of age\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic tumours. Subjects in Part 2 to have a tumour/genetic aberration.\n* Availability of tumour sample for genetic analysis\n* Adequate haemopoietic, hepatic and renal function\n* Eastern Cooperative Oncology Group performance status of 0 to 1\n* 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.\n* 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\n* Life expectancy of 12 weeks or more\n\nExclusion Criteria:\n\n* Any prior anti VEGFR/FGFR treatment related AE that in the judgement of the investigator is considered severe/life threatening\n* Subjects receiving warfarin\n* Active central nervous system metastases not controlled by prior surgery/radiotherapy and/or low dose steroids for 4 weeks or more\n* Subjects with current evidence of endocrine alteration of calcium-phosphate homeostasis\n* 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.\n* Significant cardiovascular conditions/circumstances as follows:\n* a active or unstable cardio/cerebro-vascular disease\n* b Uncontrolled hypertension (systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 90mg Hg with optimised antihypertensive therapy.\n* c history of severe arrhythmia, familial arrhythmia, conduction abnormality or congenital long QT syndrome\n* 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\n* e Repeatable prolongation of QTcF interval ≥ 450 msec or any clinically significant abnormality in the ECG at screening in 2 out of 3 recordings\n* f Left ventricular ejection fraction \\<50% at screening\n* 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\n* Major surgery or serious infection within 21 days of the first dose of ODM-203\n* Known gastrointestinal disease or a procedure that may affect absorption of ODM 203\n* Serious concurrent medical condition or psychiatric illness\n* History and/or current evidence of ectopic mineralisation/calcification\n* Known active or past history of other primary malignancy\n* Female of child bearing potential\n* 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\n* Known hypersensitivity to the study treatment excipients\n* Any condition which in the opinion of the investigator would impair the subject's ability to comply with the study procedures\n* Participation in another interventional clinical trial/ concurrent treatment with any investigational drug within 4 weeks prior to the start of treatment with ODM 203"}, 'identificationModule': {'nctId': 'NCT02264418', 'acronym': 'KIDES-203', 'briefTitle': 'Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '3113001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ODM 203', 'description': 'Oral capsules given once daily dosage 50-800mg', 'interventionNames': ['Drug: ODM 203']}, {'type': 'EXPERIMENTAL', 'label': 'ODM-203', 'description': 'Oral tablets given once daily 200-1600mg', 'interventionNames': ['Drug: ODM 203']}], 'interventions': [{'name': 'ODM 203', 'type': 'DRUG', 'description': 'ODM 203', 'armGroupLabels': ['ODM 203']}, {'name': 'ODM 203', 'type': 'DRUG', 'description': 'ODM 203', 'armGroupLabels': ['ODM 203', 'ODM-203']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Finsen Centre', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital, Department of Oncology', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy Oncology Institute', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'W1G6AD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Sarah cannon Research Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1E6DD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'UCL Cancer Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Petri Bono, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}