Study on Niraparib Combination Therapies for Treating Advanced Prostate Cancer
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT03431350
This clinical trial is testing different combinations of the drug niraparib with other treatments to see if they are safe and effective for men with advanced prostate cancer that has not responded to hormone therapy.
Patient Parameters
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Program Overview
The study aims to find the best dose and evaluate the effectiveness and safety of niraparib when combined with other cancer treatments for men with metastatic castration-resistant prostate cancer (mCRPC). It will also assess how well niraparib and another drug, abiraterone acetate, work together in the body.
Description
This study involves testing niraparib in combination with other cancer-fighting drugs to treat men with advanced prostate cancer that has spread and is resistant to hormone therapy. There are three main combinations being tested:
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Niraparib with cetrelimab, an antibody that helps the immune system fight cancer. This part of the study will first determine the best dose and then test the combination in more patients, divided into groups based on specific biomarkers.
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Niraparib with abiraterone acetate and prednisone, specifically for patients whose cancer has certain DNA-repair gene defects.
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Niraparib with abiraterone acetate to study how these drugs are absorbed and processed in the body.
The study will have several phases, including screening, treatment, and follow-up, to monitor the effectiveness and safety of the treatments. Researchers will look at how well the drugs work, how they are processed in the body, and any side effects.
Eligibility Criteria
Exclusion Criteria
- History or current diagnosis of certain blood disorders like myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Having other active cancers that are progressing or need treatment changes in the last 2 years, except for certain types like non-muscle invasive bladder cancer, skin cancer, or breast cancer that are considered cured.
- Active infections that need treatment with medication.
- Allergies or intolerance to niraparib or its ingredients.
For Combination 3:
- Having symptoms from cancer that has spread to the brain.
- Previous progression of the disease while on treatment with abiraterone acetate and a similar type of drug called a PARP inhibitor, or stopping these treatments due to side effects.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Urological Associates of Southern Arizona, P.C. | 85741 | Tucson | Arizona |
| The Urology Center of Colorado | 80211 | Denver | Colorado |
| Mayo Clinic - Division Of Hematology/oncology | 32224 | Jacksonville | Florida |
| First Urology, PSC | 47130 | Jeffersonville | Indiana |
| Chesapeake Urology Research Associates | 21204 | Towson | Maryland |
| Michigan Institute of Urology | 48084 | Troy | Michigan |
| New York Oncology Hematology | 12208 | Albany | New York |
| Memorial Sloan Kettering Cancer Center | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Thomas Jefferson University | 19107 | Philadelphia | Pennsylvania |
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