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Niraparib

Phase 4

Prostate Carcinoma Metastatic to the Bone | Small molecule | Other |Bayer AG|Last Updated: Apr 29, 2025

Development status

Highest phase Phase 4 run by University of Miami (NCT06412120)
Phase scored for BAYRYPhase 1
Registered trials 75 across 41 sponsors since Jul 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Niraparib · 1 trial · 3 indications

Phase 1 1
NCT03076203Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)Prostate Carcinoma Metastatic to the Bone
COMPLETED14 Analytics
PHASE1COMPLETED
Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)
Prostate Carcinoma Metastatic to the Bone
NCT0307620314
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Study Endpoints

Primary Endpoints

Maximum tolerated dose of niraparib to combine with radium Ra 223 dichloride based on dose limiting toxicities graded by National Cancer Institute, Common Toxicity Criteria, version 4.0
12 weeks

There will be three dose levels of niraparib combined with standard doses of Radium 223 to be evaluated for safety

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (niraparib, radium Ra 223 dichloride)EXPERIMENTALPatients receive niraparib orally daily and radium Ra 223 dichloride IV over 1 minute every 4 weeks. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
NiraparibDRUGGiven orally
Radium Ra 223 DichlorideRADIATIONGiven intravenously
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Histologic or cytologic diagnosis of adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features * Bone metastases * Documented progressive metastatic CRPC based on at least one of the following criteria: * PSA progression defined as a mimin...

Countries:United States
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