ODM-207 in Patients With Advance Solid Tumours

• Status: Completed
• Trial end date: 2019-05-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma

Criteria

Inclusion Criteria:

• Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy

• Life expectancy >12 weeks

• Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression

• ECOG performance status of 0 to 1

Exclusion Criteria:

• History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment

• Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)

• History of or current leptomeningeal or brain metastasis or spinal cord compression.