NCT02264418

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	ODM 203	ODM 203
DRUG	ODM 203	ODM 203

Timeline

• Start date: 2014-09-18
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2014-10-15
• Last updated: 2020-01-18

Locations

8 sites across 6 countries: Denmark, Finland, France, Italy, Spain, United Kingdom