The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
Part 1: to evaluate the safety and tolerability of ODM-209, to define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ODM-209, if feasible, to define the recommended dose of ODM-209 and replacement therapy for Part 2 of the study. Part 2: to further evaluate the safety and tolerability of ODM-209, to evaluate the preliminary anticancer activity of ODM-209.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
co-administered with glucocorticoid and mineralocorticoid, orally daily
Rigshospitalet, University Hospital of Copenhagen
Copenhagen, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Institut Gustave Roussy
Villejuif, France
Maximum tolerated dose (MTD)
Highest dose level at which under 33% of patients in a cohort experience DLT
Time frame: Within first 28 days of treatment
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