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A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924766
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Niraparib Drug: Apalutamide Drug: Abiraterone Acetate Drug: Prednisone Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Pharmacokinetics Study of Niraparib Plus Androgen Receptor-Targeted Therapy (Apalutamide or Abiraterone Acetate Plus Prednisone) in Men With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : July 18, 2019
Actual Study Completion Date : July 19, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Niraparib
Participants will start with niraparib 200 mg once daily.
Other Name: JNJ-64091742

Drug: Apalutamide
Participants will receive apalutamide 240 mg (4*60 mg) once daily orally.
Other Name: ARN-509

Drug: Abiraterone Acetate
Participants will receive 1000 mg (4*250mg) once daily.
Other Name: ZYTIGA

Drug: Prednisone
Participants will receive 10 mg (1*5 mg twice daily).


Outcome Measures
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Primary Outcome Measures :
  1. Determine Recommended Phase 2 dose (RP2D) of Niraparib in Combination With 240 milligram (mg) Apalutamide or 1,000 mg Abiraterone Acetate Plus 10 mg Prednisone (5 mg Twice Daily) in Part 1 [ Time Frame: Up to 56 days ]
    RP2D will be defined as the highest dose of study drug at which less than 33 percent (%) of participants experience dose limiting toxicity (DLT).

  2. Number of Participants With Incidence and Severity of Adverse Events (Part 2) [ Time Frame: Up to 30 days after last dose ]
    Number of participants will be assessed to further explore safety and antitumor activity in Part 2 (dose expansion) of study.


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days) ]
    Maximum observed plasma concentration (Cmax) will be assessed.

  2. Time to Reach the Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days) ]
    Time to reach the maximum plasma concentration(Tmax) will be assessed.

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) [ Time Frame: 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days) ]
    Area under plasma concentration-time curve from time 0 to time 24 hours after dosing will be assessed.

  4. Trough Plasma Concentration (Ctrough) [ Time Frame: Predose (Cycle 1 Days 15 and 22) up to Cycle 3 Day 1 (each cycle 28 days) then Every 3 Cycles after Cycle 3 till End of Treatment (30 days after last dose) ]
    Ctrough is the minimum observed (that is, predose) plasma concentration following multiple dosing will be assessed.

  5. Metabolite to Parent Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24]) [ Time Frame: 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days) ]
    Metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to 24 hours (AUC [0-24]) will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924766


Locations
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United States, California
West Hollywood, California, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Oregon
Portland, Oregon, United States
United States, South Carolina
Myrtle Beach, South Carolina, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02924766    
Other Study ID Numbers: CR108230
2016-002694-35 ( EudraCT Number )
64091742PCR1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Abiraterone Acetate
Niraparib
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors