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Prostatic NeoplasmsPhase 1NCT02924766

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

A Phase 1 study testing Niraparib, Apalutamide and Abiraterone Acetate in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Niraparib, Apalutamide and Abiraterone Acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
6 sitesin 2 countries
Study dates
3 Oct 2016to 19 Jul 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States4 sites

  • Study site

    Louisville, Kentucky

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Portland, Oregon

  • Study site

    West Hollywood, California

Other trials in United States

Canada2 sites

  • Study site

    Montreal, Quebec

  • Study site

    Vancouver, British Columbia

Other trials in Canada

About this study

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

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.

Being tested
Niraparib, Apalutamide, Abiraterone Acetate, Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Also called JNJ-64091742

    Participants will start with niraparib 200 mg once daily.

  • ApalutamideDrug

    Also called ARN-509

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

  • Abiraterone AcetateDrug

    Also called ZYTIGA

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

  • PrednisoneDrug

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

Study groups in NCT02924766
Study groupRoleWhat they receive
Niraparib + Apalutamide/[Abiraterone Acetate + Prednisone]ExperimentalParticipants 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.
Receives: Drug: Niraparib; Drug: Apalutamide; Drug: Abiraterone Acetate; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    RP2D will be defined as the highest dose of study drug at which less than 33 percent (%) of participants experience dose limiting toxicity (DLT).

    Measured: Up to 56 days

  2. Number of Participants With Incidence and Severity of Adverse Events (Part 2)

    Number of participants will be assessed to further explore safety and antitumor activity in Part 2 (dose expansion) of study.

    Measured: Up to 30 days after last dose

Secondary outcomes (5)

  1. Maximum Observed Plasma Concentration (Cmax)

    Maximum observed plasma concentration (Cmax) will be assessed.

    Measured: 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days)

  2. Time to Reach the Maximum Observed Plasma Concentration (Tmax)

    Time to reach the maximum plasma concentration(Tmax) will be assessed.

    Measured: 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days)

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24])

    Area under plasma concentration-time curve from time 0 to time 24 hours after dosing will be assessed.

    Measured: 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days)

  4. Trough Plasma Concentration (Ctrough)

    Ctrough is the minimum observed (that is, predose) plasma concentration following multiple dosing will be assessed.

    Measured: 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)

  5. Metabolite to Parent Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])

    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.

    Measured: 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study start3 Oct 2016
  3. Primary completion18 Jul 2019
  4. Study completion19 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02924766
Sponsor's protocol ID
CR108230
Other IDs
2016-002694-35, 64091742PCR1001, 2016
Status last verified
Jul 2020
First submitted
4 Oct 2016
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Russu A, Hazra A, Tian H, Haddish-Berhane N, Perez Ruixo JJ, Boulton M. Population Pharmacokinetics of Niraparib/Abiraterone Acetate Administered as Single-Agent Combination and Dual-Acting Tablets Plus Prednisone for Metastatic Castration-Resistant Prostate Cancer. Adv Ther. 2025 Apr;42(4):1860-1880. doi: 10.1007/s12325-025-03104-y. Epub 2025 Feb 28.

    PubMed 40016438

  • Saad F, Chi KN, Shore ND, Graff JN, Posadas EM, Lattouf JB, Espina BM, Zhu E, Yu A, Hazra A, De Meulder M, Mamidi RNVS, Bradic B, Francis P, Hayreh V, Rezazadeh Kalebasty A. Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE). Cancer Chemother Pharmacol. 2021 Jul;88(1):25-37. doi: 10.1007/s00280-021-04249-7. Epub 2021 Mar 22.

    PubMed 33754187

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Niraparib, Apalutamide and Abiraterone Acetate in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02924766, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.

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