Niraparib + Abiraterone for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you can continue gonadotropin-releasing hormone analogues (GnRHa) therapy if you haven't had a bilateral orchiectomy (surgical removal of both testicles).
Is the combination of Niraparib and Abiraterone safe for humans?
The combination of Niraparib with Abiraterone Acetate and Prednisone has shown a manageable safety profile in patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate, when used with Prednisone, is generally well tolerated, though it can cause known side effects like liver issues and effects related to steroid use.12345
What makes the drug combination of Niraparib and Abiraterone unique for prostate cancer treatment?
The combination of Niraparib and Abiraterone for prostate cancer is unique because it combines a PARP inhibitor (Niraparib) with a drug that blocks androgen production (Abiraterone), potentially offering a novel approach to targeting cancer cells in patients with specific genetic profiles, unlike standard treatments that typically use Abiraterone with prednisone alone.26789
What data supports the effectiveness of the drug combination of Niraparib and Abiraterone Acetate for prostate cancer?
The combination of Niraparib with Abiraterone Acetate and Prednisone showed promising effectiveness in patients with metastatic castration-resistant prostate cancer, particularly those with specific genetic alterations, according to the phase II QUEST study. Additionally, Abiraterone Acetate plus Prednisone has been shown to improve survival in men with castration-resistant prostate cancer in the COU-AA-302 trial.12101112
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
Men with metastatic castration-resistant prostate cancer (mCRPC) who may benefit from the study treatments. Participants should be able to continue hormone therapy if not surgically castrated, have a performance status indicating they are relatively active and can care for themselves, and must provide a tumor sample for genetic testing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various formulations of niraparib and abiraterone acetate to assess bioavailability and bioequivalence
Extension
Participants continue to receive treatment with niraparib and AAP or AAP alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone Acetate (AA)
- Niraparib
- Prednisone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University