Safety and Pharmacokinetics of ODM-209

Phase 1

Completed

• Conditions: Metastatic Breast Cancer; Castration-resistant Prostate Cancer; Prostate Cancer Metastatic; Advanced Breast Cancer
• Interventions: Drug: ODM-209

• Registration Number: NCT03878823
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Study Start: 2019-04-17
• Status Verified: 2024-01
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ODM-209 Part 2 Dose expansion	ODM-209	-
ODM-209 Part 1 Dose escalation	ODM-209	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	Within first 28 days of treatment	Highest dose level at which under 33% of patients in a cohort experience DLT

Trial Locations

Locations (4)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Rigshospitalet, University Hospital of Copenhagen; 🇩🇰 Copenhagen, Denmark

Tampere University Hospital; 🇫🇮 Tampere, Finland