Spots Global Cancer Trial Database for Safety and Pharmacokinetics of ODM-209
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Trial Identification
Brief Title: Safety and Pharmacokinetics of ODM-209
Official Title: Safety and Pharmacokinetics of ODM-209 in Patients With Metastatic Castration-resistant Prostate Cancer or Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer
Study ID: NCT03878823
Interventions
Study Description
Brief Summary: The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rigshospitalet, University Hospital of Copenhagen, Copenhagen, , Denmark
Helsinki University Central Hospital, Helsinki, , Finland
Tampere University Hospital, Tampere, , Finland
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Jutta Hänninen
Affiliation: Orion Corporation, Orion Pharma
Role: STUDY_DIRECTOR
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