A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)
Completed · Phase 1
Conditions studied: Prostatic Neoplasms
In brief
The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.
Key facts
- Study ID
- NCT02924766
- Run by
- Janssen Research & Development, LLC
- People needed
- 34
- Starts
- 2016-10-03
- Expected to finish
- 2019-07-19
- Last updated by the study team
- 2020-07-20
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded
- At least 1 line of prior taxane-based chemotherapy
- At least 1 line of prior androgen receptor (AR) targeted therapy
- Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of lesser than or equal to [<=]1
You may not qualify if…
- Known brain metastases or history of seizure
- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
- Prior platinum-based chemotherapy for the treatment of prostate cancer
- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
- Severe or unstable cardiovascular disease or uncontrolled hypertension
- Left ventricular ejection fraction (LVEF) of lesser than [<] 50 percent (%) as determined by multiple uptake gated acquisition (MUGA) or echocardiography during screening
Where it is running
- Study site — West Hollywood, California, United States
- Study site — Louisville, Kentucky, United States
- Study site — Portland, Oregon, United States
- Study site — Myrtle Beach, South Carolina, United States
- Study site — Vancouver, British Columbia, Canada
- Study site — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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