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

NCT02264418 | Completed Phase 1 DMC

• 1 other identifier: 3113001
• Study Type: interventional
• Target: 84
• Locations: 6 countries
• Sites: 8

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.

Conditions

Solid Tumours

Keywords

Solid tumours

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  Number of adverse event counts

  From the date of informed consent to the date of the end of study visit estimated to be 6 months

Secondary Outcomes (4)

• Frequency of responders to Response evaluation criteria in solid tumours (RECIST)

  Subjects will be followed for the duration of time in the study, expected to be an average of 6 months

• Eastern Cooperative Oncology Group (ECOG) Performance status

  Subjects will be followed for the duration of time in the study, expected to be an average of 6 months

• Area under the plasma concentration curve (AUC)

  0 to 24hours post dose Day 1 and Day 15

• Peak plasma concentration (Cmax)

  After first dose administration to 24 hours Day 1 and Day 15

Study Arms (2)

ODM 203

EXPERIMENTAL

Oral capsules given once daily dosage 50-800mg

Drug: ODM 203

ODM-203

EXPERIMENTAL

Oral tablets given once daily 200-1600mg

Drug: ODM 203

Interventions

ODM 203 DRUG

ODM 203

ODM 203

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (8)

Finsen Centre

Copenhagen, Denmark

Location

Helsinki University Central Hospital, Department of Oncology

Helsinki, 00029, Finland

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Gustave Roussy Oncology Institute

Villejuif, 94805, France

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Sarah cannon Research Institute

London, W1G6AD, United Kingdom

Location

UCL Cancer Institute

London, WC1E6DD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33262202 DERIVED

Study Officials

• Petri Bono, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: October 15, 2014
• Study Start: September 18, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

ES (1); GB (2); FR (2); IT (1); DK (1); FI (1)