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 : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Niraparib Drug: Apalutamide Drug: Abiraterone Acetate Drug: Prednisone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||July 2019|
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.
Participants will start with niraparib 200 mg once daily.
Other Name: JNJ-64091742
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
Participants will receive 10 mg (1*5 mg twice daily).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|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|
|Montreal, Quebec, Canada|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|