ODM-207 in Patients With Advance Solid Tumours

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: ODM-207

• Registration Number: NCT03035591
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-22
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-30
• Primary Completion: 2019-05-10
• Study Completion: 2019-05-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ODM-207	ODM-207	Escalating doses of ODM-207

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	28 days	Highest dose level at which \<33% of patients in a cohort experience Dose Limiting Toxicity (DLT)

Trial Locations

Locations (1)

Helsinki University Central Hospital, Department of Oncology; 🇫🇮 Helsinki, Finland