Prostate Cancer Clinical Trial

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Summary

The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).

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Full Description

This multicenter study will evaluate safety and efficacy of niraparib in combination with other anti-cancer agents. Combination 1 will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal antibody cetrelimab, in participants with mCRPC. Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to establish RP2D doses of niraparib and cetrelimab; and Part 2 (dose expansion) will evaluate the combination therapy in an expanded number of participants into 2 cohorts (biomarker positive or biomarker negative). Combination 2 will combine niraparib with abiraterone acetate plus prednisone (AA-P) in mCRPC participants with DNA-repair gene defects (DRD). Combination 3 will evaluate the relative bioavailability (BA) of niraparib and AA in combination. In a pharmacokinetics (PK) assessment phase, niraparib and AA will be administered, and in an extension phase, niraparib and AA-P will be administered. Combinations 1 and 2 will have 5 phases: A Pre-screening Phase, a Screening Phase, a Treatment Phase, a Follow-up Phase, and a Long-term Extension (LTE) Phase; Combination 3 has 3 phases: A Screening Phase, A PK Assessment Phase, an Extension Phase (including LTE phase). Study evaluations will include efficacy, PK, PK/pharmacodynamics, biomarkers, safety and tolerability.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for Combination 3:

Diagnosed with mCRPC, who in the opinion of the investigator may benefit from treatment in Combination 3 of this study
Able to continue gonadotropin releasing hormone analogue (GnRHa) therapy during the study if not surgically castrate (that is, subjects who has not undergone bilateral orchiectomy).
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade <= 1 (except alopecia or Grade <= 2 neuropathy) at screening
Participant must agree not to donate sperm while on study treatment, and for 3 months following the last dose of study treatment

Exclusion Criteria:

History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: non-muscle invasive bladder cancer; skin cancer (non-melanoma or melanoma); breast cancer; malignancy that is considered cured with minimal risk of recurrence
Active infection requiring systemic therapy
Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients

Combination 3:

Symptomatic brain metastases
Prior disease progression during combination treatment with AA and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT03431350

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 50 Locations for this study

See Locations Near You

Urological Associates of Southern Arizona, P.C.
Tucson Arizona, 85741, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Mayo Clinic - Division Of Hematology/oncology
Jacksonville Florida, 32224, United States
First Urology, PSC
Jeffersonville Indiana, 47130, United States
Chesapeake Urology Research Associates
Towson Maryland, 21204, United States
Michigan Institute of Urology
Troy Michigan, 48084, United States
New York Oncology Hematology
Albany New York, 12208, United States
Memorial Sloan Kettering Cancer Center
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh Pennsylvania, 15232, United States
MUSC-Hollings Cancer Center
Charleston South Carolina, 29425, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Urology Associates
Nashville Tennessee, 37209, United States
Houston Metro Urology
Houston Texas, 77027, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Urology of Virginia, PLCC
Virginia Beach Virginia, 23462, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
OLV Ziekenhuis Aalst
Aalst , 9300, Belgium
ZNA Middelheim
Antwerpen , 2020, Belgium
ULB Hôpital Erasme
Brussels , 1070, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liege , B-400, Belgium
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary Alberta, T2V 1, Canada
British Columbia Cancer Agency
Vancouver British Columbia, V5Z4E, Canada
University Health Network UHN Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Centre de Recherche du CHUM
Montreal Quebec, H2X 0, Canada
Asaf Harofe Medical Center
Beer Yaakov , 60930, Israel
Soroka Hospital
Beer-Sheva , 85101, Israel
Rambam Medical Center
Haifa , 31096, Israel
Rabin Medical Center
Petach Tikva , 49100, Israel
Sheba Medical Center Tel Hashomer
Ramat Gan , 52621, Israel
Azienda Ospedaliera Universitaria Careggi di Firenze
Firenze , 50134, Italy
Azienda Ospedaliera ''Vito Fazzi''
Lecce , 73100, Italy
UOC Oncologia Ospedale Provinciale di Macerata
Macerata , 62100, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
IRCCS-Fondazione Pascale
Napoli , 80131, Italy
Hosp. de La Santa Creu I Sant Pau
Barcelona , 08025, Spain
Hospital Vall D'Hebron
Barcelona , 8035, Spain
Hosp. Univ. de La Princesa
Madrid , 28006, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Virgen de La Victoria
Malaga , 29010, Spain
Royal United Hospital
Bath , BA1 3, United Kingdom
University College London Hospitals
London , WC1E , United Kingdom
Southampton General Hospital
Southampton , SO16 , United Kingdom
The Royal Marsden NHS Trust Sutton
Sutton , SM2 5, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT03431350

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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