Safety and Pharmacokinetics of ODM-209

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer, Metastatic Breast Cancer

Intervention / Treatment
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* Drug: ODM-209


Participation Criteria
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Eligibility Criteria
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MAIN INCLUSION CRITERIA: Written informed consent (IC) obtained. Age ≥ 18 years. ECOG performance status 0-1. Adequate marrow, liver and kidney function. Able to swallow study treatment. Main Prostate cancer specific inclusion criteria: Histologically confirmed adenocarcinoma of the prostate. Castration resistant prostate cancer with serum testosterone < 50 ng/dl. Metastatic disease. Ongoing androgen deprivation therapy with GnRH analogue, or have had bilateral orchiectomy. Have had treatment with at least one line of second generation androgen receptor targeting therapy and one line of chemotherapy. Main Breast cancer specific inclusion criteria: Histologically confirmed breast carcinoma ER positive, HER2-negative advanced breast cancer Postmenopausal or pre/perimenopausal if amendable to be treated with GnRH agonist or antagonist. Documented disease progression after treatment with at least 2 lines of systemic treatment for advanced breast cancer. Of these, at least one line must have been endocrine treatment in combination with a cdk4/6 inhibitor. MAIN EXCLUSION CRITERIA History of pituitary dysfunction. Known brain metastases or active leptomeningeal disease. Active infection or other medical condition that would make corticosteroids contraindicated. Hypotension or uncontrolled hypertension. Clinically significant cardiovascular disease, e.g. myocardial infarction, arterial thrombotic events, or pulmonary embolism in the past six months, unstable angina, or congestive heart failure (New York Heart Association [NYHA] class II-IV). Prolonged QTcF interval. Use of any investigational drug 4 weeks prior to the start of the study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODM-209 Part 1 Dose escalation<br> | Drug: ODM-209<br>* co-administered with glucocorticoid and mineralocorticoid, orally daily<br>|
| Experimental: ODM-209 Part 2 Dose expansion<br> | Drug: ODM-209<br>* co-administered with glucocorticoid and mineralocorticoid, orally daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) | Highest dose level at which under 33% of patients in a cohort experience DLT | Within first 28 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic castration-resistant prostate cancer, advanced hormone receptor positive breast cancer