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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02264418
• Date of registration: 19/09/2014
• Prospective Registration: No
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours KIDES-203
• Scientific 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
• Date of first enrolment: September 18, 2014
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02264418
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Denmark, Finland, France, Italy, Spain, United Kingdom

Contacts

• Name: Petri Bono, MD
• Affiliation: Helsinki University Central Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Solid Tumours

Intervention(s)

Drug: ODM 203

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Peak plasma concentration (Cmax) [Time Frame: After first dose administration to 24 hours Day 1 and Day 15]

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

Secondary ID(s)

3113001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors