ODM-207 in Patients With Advance Solid Tumours (BETIDES)

Orion Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: ODM-207

Study type: Interventional

Funder types: Industry

Identifiers

NCT03035591

3121001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

ODM-207

Experimental group

Description:

Escalating doses of ODM-207

Treatment:

Drug: ODM-207