Clinical Trial - NCT02854436

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Recruiting

Sponsor: Janssen Research & Development, LLC

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02854436

Protocol Info

Short Description: An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies (Galahad)
Long Description: A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration- Resistant Prostate Cancer and DNA-Repair Anomalies
MGH Status: Open
Sponsor: Janssen
Disease Program: GU

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
Condition Title Intervention Phase
Prostatic Neoplasms Niraparib Phase 2
Study Type Interventional
Official Title A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Primary Outcome Measures

Objective Response Rate (ORR) [Time Frame: Screening, Cycle 1 (each cycle of 28 days) Day 1 (every 8 weeks for the first 6 months and then every 12 weeks thereafter) till Follow-up Phase] [Designated as safety issue: ]


Secondary Outcome Measures

Objective Response Rate (ORR) [Time Frame: Approximately up to 3 years and 2 months] [Designated as safety issue: ]

Circulating Tumor Cells (CTC) Response [Time Frame: From Screening till End of Treatment (30 {+/- 5} days of last dose - approximately up to 3 years and 2 months)] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)] [Designated as safety issue: ]

Radiographic Progression-Free Survival (rPFS) [Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)] [Designated as safety issue: ]

Time to Prostate Specific Antigen (PSA) Progression [Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)] [Designated as safety issue: ]

Time to Symptomatic Skeletal Event (SSE) [Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)] [Designated as safety issue: ]

Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)] [Designated as safety issue: ]

Duration of Objective Response [Time Frame: From complete response (CR) or partial response (PR) to radiographic progression of disease (approximately up to 3 years and 2 months)] [Designated as safety issue: ]

Estimated Enrollment: 301
Study Start Date: August 2016
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: October 2019
Arms Assigned Interventions

Experimental:Niraparib

Participants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily.
Drug:Niraparib
Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Male

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded)
  • Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event
  • Received androgen receptor (AR)-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression
  • Biomarker-positive for deoxyribonucleic acid (DNA)-repair anomalies
  • Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry

Exclusion Criteria:

  • 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)
  • Symptomatic or impending cord compression
  • Symptomatic brain metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02854436

Locations

  • United States, Arizona
    • Urological Associates of Southern Arizona, P.C. Tucson, Arizona, United States, 85741
  • United States, California
    • University of Southern California Los Angeles, California, United States, 90089
    • Kaiser Permanente Riverside, California, United States, 92505
    • UC Davis Comprehensive Cancer Center Sacramento, California, United States, 95817
    • University Of California San Francisco, California, United States, 94158
    • Stanford University School of Medicine Stanford, California, United States, 94305
    • Cedars-Sinai Medical Center West Hollywood, California, United States, 90048
  • United States, Colorado
    • University of Colorado Health Sciences Center Aurora, Colorado, United States, 80045
    • The Urology Center of Colorado Denver, Colorado, United States, 80211
  • United States, Illinois
    • Northshore Universite Healthsystem Evanston, Illinois, United States, 60201
  • United States, Kentucky
    • Commonwealth Cancer Center Danville, Kentucky, United States, 40422
    • Norton Healthcare Louisville, Kentucky, United States, 40202
  • United States, Louisiana
    • Oncology & Hematology Specialists Metairie, Louisiana, United States, 70006
    • Tulane University School of Medicine New Orleans, Louisiana, United States, 70112
  • United States, Maryland
    • Chesapeake Urology Research Associates Baltimore, Maryland, United States, 21204
  • United States, Massachusetts
    • Massachusetts General Boston, Massachusetts, United States, 02115
  • United States, Michigan
    • Barbara Ann Karmanos Cancer Institute Detroit, Michigan, United States, 48201
  • United States, New York
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
  • United States, North Carolina
    • Duke Cancer Institute Durham, North Carolina, United States, 27710
  • United States, Oregon
    • Oregon Health & Science University Portland, Oregon, United States, 97239
  • United States, Pennsylvania
    • Lancaster Urology Lancaster, Pennsylvania, United States, 17601
    • Jefferson Medical Oncology Associates Philadelphia, Pennsylvania, United States, 19107
  • United States, South Carolina
    • Atlantic Urology Clinics Myrtle Beach, South Carolina, United States, 29572
  • United States, Texas
    • MD Anderson Cancer Center Houston, Texas, United States, 77030
    • Millennium Oncology Houston, Texas, United States, 77090
  • United States, Utah
    • Intermountain Healthcare Saint George, Utah, United States, 84770
  • United States, Virginia
    • University of Virginia Charlottesville, Virginia, United States, 22908
    • INOVA Fairfax, Virginia, United States, 22031
  • United States, Washington
    • University of Washington School of Medicine Seattle, Washington, United States, 98195
  • United States, Wisconsin
    • University of Wisconsin Carbone Cancer Center Madison, Wisconsin, United States, 53792
  • Australia,
    • Chris O'Brien Lifehouse Camperdown, , Australia, 2050
    • St. Vincent's Hospital Sydney Darlinghurst, , Australia, 2010
    • Border Medical Oncology East Albury, , Australia, 2640
    • Ashford Cancer Centre Kurralta Park, , Australia, 5037
    • Peter MacCallum Cancer Centre Melbourne, , Australia, 3000
    • Fiona Stanley Hospital Murdoch, , Australia, 6150
    • Macquarie University Hospital North Ryde, , Australia, 2109
    • Port Macquarie Base Hospital Port Macquarie, , Australia, 2444
    • Prince Of Wales Hospital Randwick, , Australia, 2031
    • Sydney Adventist Hospital Wahroonga, , Australia, 2076
  • Belgium,
    • OLV Ziekenhuis Aalst Aalst, , Belgium, 9300
    • Institut Jules Bordet Brussel, , Belgium, 1000
    • Grand Hôpital de Charleroi, site Notre Dame Charleroi, , Belgium, 6000
    • AZ Maria Middelares Gent, , Belgium, 9000
    • Universitair Ziekenhuis Gent Gent, , Belgium, 9000
    • Jolimont Haine-Saint-Paul, La Louviere, , Belgium, 7100
    • Virga Jessa Ziekenhuis Hasselt, , Belgium, 3500
    • Az Groeninge Kortrijk, , Belgium, 8500
    • Sart Tilman Liège, , Belgium, 4000
    • Clinique et Maternité Sainte Elisabeth Namur, , Belgium, 5000
    • Clinique St Pierre Ottignies, , Belgium, 1340
    • GZA Ziekenhuizen- Campus St Augustinus Wilrijk, , Belgium, 2610
  • Brazil,
    • Hospital Do Cancer De Barretos - Fundacao Pio Xii Barretos, , Brazil, 14784-400
    • PERSONAL - Oncologia de Precisão e Personalizada Belo Horizonte, , Brazil, 30130-090
    • Hospital Erasto Gaertner Curitiba, , Brazil, 81520-060
    • Pronutrir Fortaleza, , Brazil, 60 810180
    • Hospital de Caridade de Ijui Ijuí, , Brazil, 98700-000
    • Clínica de Neoplasias Litoral Ltda. Itajai, , Brazil, 88301-220
    • Instituto Joinvilense De Hematologia e Oncologia Joinville, , Brazil, 89201260
    • Liga Norte Riograndense Contra O Cancer Natal, , Brazil, 59075-740
    • Hospital Sao Rafael Salvador, , Brazil, 41253-190
    • Instituto de Ensino E Pesquisa Sao Lucas Sao Paulo, , Brazil, 01236-030
    • Hospital Israelita Albert Einstein São Paulo, , Brazil, 05651-900
  • Canada, Alberta
    • Prostate Cancer Centre Calgary, Alberta, Canada, T2V 1P9
  • Canada, British Columbia
    • British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI) Kelowna, British Columbia, Canada, V1Y 5L3
    • British Columbia Cancer Agency (BCCA) - Vancouver Centre Vancouver, British Columbia, Canada, V5Z 4E6
  • Canada, Ontario
    • Lakeridge Health Oshawa Oshawa, Ontario, Canada,
    • Sunnybrook Health Sciences Center Toronto, Ontario, Canada, M4N 3M5
    • University Health Network (UHN) Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • Centre de Recherche du CHUM Montreal, Quebec, Canada, H2X 0A9
  • Canada,
    • Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc Quebec, , Canada, G1R2J6
  • Denmark,
    • Aalborg University Hospital Aalborg, , Denmark, 9000
    • Aarhus University Hospital Aarhus N., , Denmark, 8200
    • Copenhagen University Hospital Copenhagen, , Denmark, 2100
    • Rigshospitalet Copenhagen, , Denmark, 2100
    • Gentofte Herlev Hospital Herlev, , Denmark, 2730
    • Herlev Hospital Herlev, , Denmark, 2730
    • Odense Universitetshospital Odense C, , Denmark, 5000
  • France,
    • Institut Sainte Catherine Avignon Cedex 9, , France, 84918
    • CHRU De Besancon Besancon, , France, 25030
    • Centre Francois Baclesse Caen, , France, 14000
    • Centre Leon Bérard Lyon, , France, 69008
    • Centre Antoine Lacassagne Nice Cedex 2, , France, 06189
    • Hôpital Saint Louis Paris, , France, 75010
    • Hopital Europeen Georges-Pompidou Paris, , France, 75015
    • Institut Jean Godinot Reims, , France, 51100
    • Hôpitaux Universitaire de Strasbourg -CHU Strasbourg, , France, 67091
    • Gustave Roussy Villejuif Cedex, , France, 94805
  • Israel,
    • Soroka Hospital Beer-Sheva, , Israel, 85101
    • Rambam Hospital Haifa, , Israel, 31096
    • Hadassah Medical Organization Ein Kerem Jerusalem, , Israel, 91120
    • Meir Hospital Kfar Saba, , Israel, 44281
    • Sheba Medical Center Ramat Gan, , Israel, 74047
    • Asaf Harofe Medical Center Zrifin, , Israel, 60930
  • Korea, Republic of,
    • Severance Hospital Seoul, , Korea, Republic of, 03722
    • Asan Medical Center Seoul, , Korea, Republic of, 05505
    • Gangnam Severance Hospital Seoul, , Korea, Republic of, 06273
    • Samsung Medical Center Seoul, , Korea, Republic of, 06351
    • The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, , Korea, Republic of, 06591
  • Netherlands,
    • Mc Alkmaar Alkmaar, , Netherlands, 1815 JD
    • VUMC Amsterdam Amsterdam, , Netherlands, 1081 HV
    • Universitair Medisch Centrum Groningen Groningen, , Netherlands, 9713 GZ
    • AZ Maastricht Maastricht, , Netherlands, 6202
    • Radboudumc Nijmegen, , Netherlands, 6525 GA
    • Erasmus MC Rotterdam, , Netherlands, 3015 GD
  • Russian Federation,
    • Russian Scientific Center of Roentgenoradiology Moscow, , Russian Federation, 117997
    • Moscow City Clinical Hospital # 62 Moscow, , Russian Federation, 125130
    • Hertzen Oncology Research Institute Moscow, , Russian Federation, 125284
    • Clinical Oncology Dispansary Omsk, , Russian Federation, 644013
    • Tomsk Cancer Research Institute Tomsk, , Russian Federation, 634050
  • Spain,
    • Hosp. de La Santa Creu I Sant Pau Barcelona, , Spain, 08025
    • Hosp. Univ. Vall D Hebron Barcelona, , Spain, 08035
    • Hosp. Clinic I Provincial de Barcelona Barcelona, , Spain, 08036
    • Hosp. Reina Sofia Córdoba, , Spain, 14004
    • Hosp. Gral. Univ. Gregorio Maranon Madrid, , Spain, 28007
    • Hosp. Clinico San Carlos Madrid, , Spain, 28040
    • Hosp. Univ. Hm Sanchinarro Madrid, , Spain, 28050
    • Hosp. Virgen de La Victoria Málaga, , Spain, 29010
    • Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcon, , Spain, 28223
    • Hosp. Univ. Marques de Valdecilla Santander, , Spain, 39008
    • Hosp. Clinico Univ. de Santiago Santiago de Compostela, , Spain, 15706
    • Hosp. Virgen Del Rocio Sevilla, , Spain, 41013
    • Hosp. Univ. I Politecni La Fe Valencia, , Spain, 46026
  • Sweden,
    • Salgrenska University hospital Göteborg, , Sweden, 413 45
    • Lund University Hospital/Skåne Lund, , Sweden, 221 85
    • Karolinska Universitetssjukhuset Solna Stockholm, , Sweden, 17176
    • Norrlands Universitetssjukhus Umeå, , Sweden, 90185
  • Taiwan,
    • Kaohsiung Chang Gung Memorial Hospital Kaohsiung, , Taiwan, 88301
    • China Medical University Hospital Taichung, , Taiwan, 40447
    • Taichung Veterans General Hospital Taichung, , Taiwan, 40705
    • National Cheng Kung University Hospital Tainan, , Taiwan, 70403
    • National Taiwan University Hospital Taipei, , Taiwan, 10002
    • Tri-Service General Hospital Taipei, , Taiwan, 11490
    • Chang Gung Memorial Hospital Linkou Branch Taoyuan County, , Taiwan, 333
  • United Kingdom,
    • The Queen Elizabeth Hospital Birmingham, , United Kingdom, B15 2TH
    • Royal Blackburn Hospital Blackburn, , United Kingdom, BB2 3HH
    • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Bournemouth, , United Kingdom, BH7 7DW
    • Bristol Haematology and Oncology Centre Bristol, , United Kingdom, BS2 8ED
    • Velindre Hospital Cardiff, , United Kingdom, CF14 2TL
    • Royal Devon & Exeter Hospital Exeter, , United Kingdom, EX2 5DW
    • Royal Marsden Hospital London, , United Kingdom, SW7 3RP
    • University College London Hospitals London, , United Kingdom, WC1E 6BT
    • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital Preston, , United Kingdom, PR2 9HT
    • Taunton and Somerset NHS Foundation Trust Taunton, , United Kingdom, TA1 5DA

Sponsors and Collaborators

Janssen Research & Development, LLC

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02854436
Other Study ID Numbers: 64091742PCR2001
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Janssen Research & Development, LLC:

Prostate cancer

CRPC

Metastatic castrate-resistant prostate cancer

Prostate neoplasm

Galahad

Niraparib

DNA anomalies

DNA defect

PARP inhibitor

PARPi

Additional relevant MeSH terms:

Prostatic Neoplasms

Congenital Abnormalities

Niraparib

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on July 18, 2019