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

Launched by ORION CORPORATION, ORION PHARMA · Feb 12, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ODM-208 for men with metastatic castration-resistant prostate cancer, which is a type of prostate cancer that has spread to other parts of the body and does not respond to standard hormone treatments. The main goal of the trial is to assess how safe the treatment is and how well the body tolerates it.

Men who might be eligible to participate in this trial must be at least 18 years old and have been diagnosed with prostate cancer that has spread and is no longer responding to hormone therapy. They should also have been on hormone deprivation therapy or had surgery to remove their testicles. Participants will be closely monitored during the trial to ensure their safety and to understand how the treatment works in their body. It's important to note that this trial is currently active but not recruiting new participants. If you or a loved one are considering this option, it’s essential to discuss it with a healthcare provider to see if it aligns with your specific situation.

Gender

MALE

Eligibility 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.