Prostate Cancer Clinical Trial

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Summary

The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

View Full Description

Full Description

Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone which selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), that is found in the testes and adrenals (leading to systemic inhibition of testosterone production), as well as in prostate tissues and tumors. The rationale of the study is to investigate the various strengths and formulations of niraparib and AA plus prednisone or prednisolone (P) in metastatic castration resistant prostate cancer (mCRPC) participants with and without homologous recombination repair (HRR) gene alterations. In participants with metastatic prostate cancer, DNA-repair anomalies are found in approximately 15 percent (%) to 20% of tumors. This study consists 4 periods: screening phase (up to 21 days); treatment phase (up to 22 days); extension and long-term extension phases (from day 23 until discontinuation); and post-treatment follow up phase (end of treatment [EoT] visit within 30 days after the last dose of study treatment). Total duration of study is up to 1.4 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study. Participants safety will be monitored throughout the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate
Diagnosed with metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment in this study
Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy during the study if not surgically castrate (that is, participants who have not undergone bilateral orchiectomy)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
Willing to provide a tumor sample (archival) for determination of homologous recombination repair (HRR) gene alteration status

Exclusion Criteria:

Symptomatic brain metastases
Prior disease progression during treatment with abiraterone acetate (AA) alone or when combined with a poly adenosine diphosphate (ADP)-ribose polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi related toxicity.
History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
Known allergies, hypersensitivity, or intolerance to niraparib or AA or the corresponding excipients of niraparib/AA
Any medical condition that would make prednisone/prednisolone use contraindicated

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT04577833

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 16 Locations for this study

See Locations Near You

START Mountain Region
West Valley City Utah, 84119, United States
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk , 2610, Belgium
Institut Bergonié, Centre de Lutte Contre le Cancer
Bordeaux , 33000, France
HIA Begin
Saint Mande , 94163, France
Arensia Exploratory Medicine
Tbilisi , 0112, Georgia
Arensia Exploratory Medicine
Chisinau , Md202, Moldova, Republic of
Erasmus MC
Rotterdam , 3015 , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Virgen de La Victoria
Málaga , 29010, Spain
Karolinska Universitetssjukhuset Solna
Stockholm , 171 7, Sweden
ARENSIA Exploratory Medicine Unit
Kiev , 01135, Ukraine
Sir Bobby Robson Unit, Northern Centre for Cancer Care
Newcastle upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT04577833

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.