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NCT Number: NCT02924766

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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niraparib

Drug

Participants will start with niraparib 200 mg once daily.

Other names: JNJ-64091742

Apalutamide

Drug

Participants will receive apalutamide 240 mg (4*60 mg) once daily orally.

Other names: ARN-509

Abiraterone Acetate

Drug

Participants will receive 1000 mg (4*250mg) once daily.

Other names: ZYTIGA

Prednisone

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2016
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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