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Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours (KIDES-203)

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ClinicalTrials.gov Identifier: NCT02264418
Recruitment Status : Active, not recruiting
First Posted : October 15, 2014
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

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 and dose limiting toxicities.

Condition or disease Intervention/treatment Phase
Solid Tumours Drug: ODM 203 Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : September 18, 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: ODM 203
Oral capsules given once daily dosage 50-800mg
Drug: ODM 203
ODM 203

Drug: ODM 203
ODM 203

Experimental: ODM-203
Oral tablets given once daily 200-1600mg
Drug: ODM 203
ODM 203




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    The frequency of responders according to RECIST will be evaluated by dose level.

  2. 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 ]
    The ECOG performance status and the change from baseline will be reported by dose level.

  3. Area under the plasma concentration curve (AUC) [ Time Frame: 0 to 24hours post dose Day 1 and Day 15 ]
    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

  4. Peak plasma concentration (Cmax) [ Time Frame: After first dose administration to 24 hours Day 1 and Day 15 ]
    Peak plasma concentration (Cmax) of ODM-203 will be measured to evaluate the relationship between ODM-203 dose, plasma exposure, pharmacodynamics and safety



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264418


Locations
Denmark
Finsen Centre
Copenhagen, Denmark
Finland
Helsinki University Central Hospital, Department of Oncology
Helsinki, Finland, 00029
France
Institut Bergonie
Bordeaux, France, 33000
Gustave Roussy Oncology Institute
Villejuif, France, 94805
Italy
European Institute of Oncology
Milan, Italy, 20141
Spain
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
United Kingdom
Sarah cannon Research Institute
London, United Kingdom, W1G6AD
UCL Cancer Institute
London, United Kingdom, WC1E6DD
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Petri Bono, MD Helsinki University Central Hospital

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT02264418     History of Changes
Other Study ID Numbers: 3113001
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Keywords provided by Orion Corporation, Orion Pharma:
Solid tumours