Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer (CYPIDES)

Orion Pharma

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Prostate Cancer Metastatic

Treatments: Drug: Midazolam; Drug: ODM-208

Study type: Interventional

Funder types: Industry

Identifiers

NCT03436485

3124001

Details and patient eligibility

About

The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

Full description

Safety and tolerability profile of ODM-208 will be explored

Enrollment: 204 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Written informed consent (IC) obtained.
• Male aged ≥ 18 years.
• 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 antagonist, or have had bilateral orchiectomy.
• Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide).
• ECOG performance status 0-1.
• Adequate marrow, liver and kidney function.
• Able to swallow study treatment.
• Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC.

Main Exclusion Criteria:

• History of pituitary or adrenal dysfunction.
• Known brain metastases or active leptomeningeal disease.
• Active infection or other medical condition that would make corticosteroid contraindicated.
• Poorly controlled diabetes.
• Hypotension or uncontrolled hypertension.
• Clinically significantly abnormal serum potassium or sodium level.
• Active or unstable cardio/cerebro-vascular disease including thromboembolic events.
• Prolonged QTcF interval.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 3 patient groups

ODM-208 Part 1 Dose escalation

Experimental group

Treatment:

Drug: ODM-208

ODM-208 Part 2 Dose expansion

Experimental group

Treatment:

Drug: ODM-208

ODM-208 Part 2 Drug drug interaction

Experimental group

Treatment:

Drug: ODM-208

Drug: Midazolam