Trials / Completed
CompletedNCT03878823
Safety and Pharmacokinetics of ODM-209
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Orion Corporation, Orion Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Prostate Cancer Metastatic
- Advanced Breast Cancer
- Castration-resistant Prostate Cancer
- Metastatic Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ODM-209 | co-administered with glucocorticoid and mineralocorticoid, orally daily |
Timeline
- Start date
- 2019-04-17
- Primary completion
- 2024-01-09
- Completion
- 2024-01-09
- First posted
- 2019-03-18
- Last updated
- 2024-02-01
Locations
4 sites across 3 countries: Denmark, Finland, France
Source: ClinicalTrials.gov record NCT03878823. Inclusion in this directory is not an endorsement.