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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

Tracking Information
First Submitted Date  ICMJE September 19, 2014
First Posted Date  ICMJE October 15, 2014
Last Update Posted Date October 3, 2018
Actual Study Start Date  ICMJE September 18, 2014
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
Number of adverse events [ Time Frame: All visits from Screening to week 24 ]
Number of adverse event counts
Change History Complete list of historical versions of study NCT02264418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • 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.
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
  • 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.
  • 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.
  • Area under the plasma concentration curve (AUC) [ Time Frame: 0 to 24hours post dose Day 1 and Day 8 ]
    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
  • Peak plasma concentration (Cmax) [ Time Frame: After first dose administration to 24 hours Day 1 and Day 8 ]
    Peak plasma concentration (Cmax) of ODM-203 will be measured to evaluate the relationship between ODM-203 dose, plasma exposure, pharmacodynamics and safety
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Solid Tumours
Intervention  ICMJE Drug: ODM 203
ODM 203
Study Arms
  • Experimental: ODM 203
    Oral capsules given once daily dosage 50-800mg
    Interventions:
    • Drug: ODM 203
    • Drug: ODM 203
  • Experimental: ODM-203
    Oral tablets given once daily 200-1600mg
    Intervention: Drug: ODM 203
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2016)
117
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2014)
42
Estimated Study Completion Date January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   France,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02264418
Other Study ID Numbers  ICMJE 3113001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Orion Corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petri Bono, MD Helsinki University Central Hospital
PRS Account Orion Corporation, Orion Pharma
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP