A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)
NCT ID: NCT02924766
Last Updated: 2020-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2016-10-03
2019-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Niraparib + Apalutamide/[Abiraterone Acetate + Prednisone]
Participants will receive initial starting dose of Niraparib 200 milligram (mg) once daily in combination either with Apalutamide 240 mg (4\*60 mg) once daily or Abiraterone Acetate 1000 mg (4\*250 mg) plus 10 mg Prednisone (5 mg twice daily) for 28 days of cycle 1. Once a safe dose of niraparib is selected with each Andrgen Receptor (AR)-targeted therapy \[Apalutamide or Abiraterone Acetate plus Prednisone\], then an expansion phase (Part 2) will open to further explore safety and assess antitumor activity.
Niraparib
Participants will start with niraparib 200 mg once daily.
Apalutamide
Participants will receive apalutamide 240 mg (4\*60 mg) once daily orally.
Abiraterone Acetate
Participants will receive 1000 mg (4\*250mg) once daily.
Prednisone
Participants will receive 10 mg (1\*5 mg twice daily).
Interventions
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Niraparib
Participants will start with niraparib 200 mg once daily.
Apalutamide
Participants will receive apalutamide 240 mg (4\*60 mg) once daily orally.
Abiraterone Acetate
Participants will receive 1000 mg (4\*250mg) once daily.
Prednisone
Participants will receive 10 mg (1\*5 mg twice daily).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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West Hollywood, California, United States
Louisville, Kentucky, United States
Portland, Oregon, United States
Myrtle Beach, South Carolina, United States
Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Countries
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References
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Saad F, Chi KN, Shore ND, Graff JN, Posadas EM, Lattouf JB, Espina BM, Zhu E, Yu A, Hazra A, De Meulder M, Mamidi RNVS, Bradic B, Francis P, Hayreh V, Rezazadeh Kalebasty A. Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE). Cancer Chemother Pharmacol. 2021 Jul;88(1):25-37. doi: 10.1007/s00280-021-04249-7. Epub 2021 Mar 22.
Related Links
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A Safety and Pharmacokinetics Study of Niraparib plus Androgen Receptor-Targeted Therapy (Apalutamide or Abiraterone Acetate plus Prednisone) in Men with Metastatic Castration-Resistant
Other Identifiers
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2016-002694-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
64091742PCR1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108230
Identifier Type: -
Identifier Source: org_study_id
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