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NCT03035591 Clinical Trial

ODM-207 in Patients With Advance Solid Tumours

Solid Tumors Clinical Trial

— BETIDES  

Official title:
Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03035591
Other study ID # 3121001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 22, 2016
Est. completion date May 10, 2019

Study information
Verified date October 2019
Source Orion Corporation, Orion Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date May 10, 2019
Est. primary completion date May 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• ODM-207

Locations
Country Name City State
Finland Helsinki University Central Hospital, Department of Oncology Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (DLT) 28 days
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