Study on the Safety of ODM-208 for Men with Advanced Prostate Cancer
Sponsor: Orion Corporation, Orion Pharma
ClinicalTrials ID:NCT03436485
This clinical trial is testing a new drug, ODM-208, to see if it is safe and well-tolerated in men with advanced prostate cancer that has continued to grow despite low testosterone levels.
Patient Parameters
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Program Overview
The aim of this study is to evaluate the safety and tolerability of a new drug called ODM-208 in men with metastatic castration-resistant prostate cancer, which means the cancer has spread and continues to grow even when testosterone levels are low.
Description
This study focuses on understanding how safe and tolerable ODM-208 is for patients with advanced prostate cancer that has spread to other parts of the body and is resistant to treatments that lower testosterone. Researchers will monitor participants closely to see how they respond to the drug and to identify any side effects.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 years or older.
- Diagnosed with prostate cancer that has spread and is resistant to treatments lowering testosterone.
- Currently receiving hormone therapy or have had surgery to remove the testicles.
- Previously treated with at least one hormonal therapy targeting androgen receptors.
- Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Adequate blood, liver, and kidney function.
- Able to swallow the study medication.
- For Part 1: Must have received at least one chemotherapy treatment or be ineligible for chemotherapy. For Part 2: Must have received taxane-based chemotherapy for prostate cancer.
Exclusion Criteria
- History of problems with the pituitary or adrenal glands.
- Known brain cancer or active disease affecting the brain's lining.
- Active infections or medical conditions that prevent the use of corticosteroids.
- Poorly controlled diabetes.
- Low or uncontrolled high blood pressure.
- Abnormal levels of potassium or sodium in the blood.
- Active or unstable heart or blood vessel diseases, including blood clots.
- Abnormal heart rhythm as shown by a prolonged QTcF interval on an ECG.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Maryland Marlene and Stewart Greenebaum Cancer Center | 21201 | Baltimore | Maryland |
| Masonic Cancer Center, University of Minnesota | 55455 | Minneapolis | Minnesota |
| Nebraska Cancer Specialists | 68114 | Omaha | Nebraska |
| University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative | 14203 | Buffalo | New York |
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