A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)
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| ClinicalTrials.gov Identifier: NCT02924766 |
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Recruitment Status :
Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : June 21, 2019
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 participants |
| 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 2016 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | July 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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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.
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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). |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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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
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
| 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
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT02924766 History of Changes |
| 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: | June 21, 2019 |
| Last Verified: | June 2019 |
| 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 Genital Diseases, Male Prostatic Diseases Prednisone Abiraterone Acetate Niraparib Androgens 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 |