Clinical Trial - NCT02854436

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

Active, not 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: Closed
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: Up to 4 years and 6 months] [Designated as safety issue: ]

Circulating Tumor Cells (CTC) Response [Time Frame: From Screening till End of Treatment (30 {+/- 5} days of last dose -up to 4 years and 6 months)] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: From enrollment to completion of study (up to 4 years and 6 months)] [Designated as safety issue: ]

Radiographic Progression-Free Survival (rPFS) [Time Frame: From enrollment to completion of study (up to 4 years and 6 months)] [Designated as safety issue: ]

Time to Prostate Specific Antigen (PSA) Progression [Time Frame: From enrollment to completion of study (up to 4 years and 6 months)] [Designated as safety issue: ]

Time to Symptomatic Skeletal Event (SSE) [Time Frame: From enrollment to completion of study (up to 4 years and 6 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 (up to 4 years and 6 months)] [Designated as safety issue: ]

Duration of Objective Response [Time Frame: From complete response (CR) or partial response (PR) to radiographic progression of disease (up to 4 years 6 months)] [Designated as safety issue: ]

Estimated Enrollment: 291
Study Start Date: August 2016
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: January 2021
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 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 a second-generation or later 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 or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis
  • Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing)
  • 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
    • Tucson, Arizona, United States,
  • United States, California
    • Los Angeles, California, United States,
    • Riverside, California, United States,
    • Sacramento, California, United States,
  • United States, Colorado
    • Aurora, Colorado, United States,
    • Denver, Colorado, United States,
  • United States, Illinois
    • Evanston, Illinois, United States,
  • United States, Kentucky
    • Danville, Kentucky, United States,
    • Louisville, Kentucky, United States,
  • United States, Louisiana
    • New Orleans, Louisiana, United States,
  • United States, Massachusetts
    • Boston, Massachusetts, United States,
  • United States, Michigan
    • Detroit, Michigan, United States,
  • United States, Nebraska
    • Omaha, Nebraska, United States,
  • United States, New York
    • New York, New York, United States,
  • United States, North Carolina
    • Durham, North Carolina, United States,
  • United States, Pennsylvania
    • Lancaster, Pennsylvania, United States,
    • Philadelphia, Pennsylvania, United States,
  • United States, South Carolina
    • Myrtle Beach, South Carolina, United States,
  • United States, Texas
    • Houston, Texas, United States,
  • United States, Virginia
    • Charlottesville, Virginia, United States,
    • Fairfax, Virginia, United States,
  • United States, Washington
    • Seattle, Washington, United States,
  • United States, Wisconsin
    • Madison, Wisconsin, United States,
  • Australia,
    • Camperdown, , Australia,
    • Darlinghurst, , Australia,
    • East Albury, , Australia,
    • Kurralta Park, , Australia,
    • Melbourne, , Australia,
    • Murdoch, , Australia,
    • North Ryde, , Australia,
    • Port Macquarie, , Australia,
    • Randwick, , Australia,
    • Wahroonga, , Australia,
  • Belgium,
    • Aalst, , Belgium,
    • Brussel, , Belgium,
    • Charleroi, , Belgium,
    • Gent, , Belgium,
    • Haine-Saint-Paul, La Louviere, , Belgium,
    • Hasselt, , Belgium,
    • Kortrijk, , Belgium,
    • Liège, , Belgium,
    • Namur, , Belgium,
    • Ottignies, , Belgium,
    • Wilrijk, , Belgium,
  • Brazil,
    • Barretos, , Brazil,
    • Belo Horizonte, , Brazil,
    • Curitiba, , Brazil,
    • Fortaleza, , Brazil,
    • Ijuí, , Brazil,
    • Itajai, , Brazil,
    • Joinville, , Brazil,
    • Natal, , Brazil,
    • Salvador, , Brazil,
    • Sao Paulo, , Brazil,
  • Canada, British Columbia
    • Vancouver, British Columbia, Canada,
  • Canada, Ontario
    • Oshawa, Ontario, Canada,
    • Toronto, Ontario, Canada,
  • Canada, Quebec
    • Montreal, Quebec, Canada,
  • Canada,
    • Quebec, , Canada,
  • Denmark,
    • Aarhus N., , Denmark,
    • Copenhagen, , Denmark,
    • Herlev, , Denmark,
    • Odense C, , Denmark,
  • France,
    • Avignon Cedex 9, , France,
    • Besancon, , France,
    • Caen, , France,
    • Lyon, , France,
    • Nice Cedex 2, , France,
    • Paris, , France,
    • Reims, , France,
    • Strasbourg, , France,
    • Villejuif Cedex, , France,
  • Israel,
    • Beer-Sheva, , Israel,
    • Haifa, , Israel,
    • Kfar Saba, , Israel,
    • Ramat Gan, , Israel,
    • Zrifin, , Israel,
  • Korea, Republic of,
    • Seoul, , Korea, Republic of,
  • Netherlands,
    • Alkmaar, , Netherlands,
    • Amsterdam, , Netherlands,
    • Groningen, , Netherlands,
    • Maastricht, , Netherlands,
    • Rotterdam, , Netherlands,
  • Russian Federation,
    • Moscow, , Russian Federation,
    • Omsk, , Russian Federation,
    • Tomsk, , Russian Federation,
  • Spain,
    • Barcelona, , Spain,
    • Córdoba, , Spain,
    • Madrid, , Spain,
    • Málaga, , Spain,
    • Pozuelo de Alarcon, , Spain,
    • Santander, , Spain,
    • Santiago de Compostela, , Spain,
    • Sevilla, , Spain,
    • Valencia, , Spain,
  • Sweden,
    • Göteborg, , Sweden,
    • Lund, , Sweden,
    • Stockholm, , Sweden,
    • UmeÃ¥, , Sweden,
  • Taiwan,
    • Kaohsiung, , Taiwan,
    • Taichung, , Taiwan,
    • Tainan, , Taiwan,
    • Taipei, , Taiwan,
    • Taoyuan County, , Taiwan,
  • United Kingdom,
    • Bristol, , United Kingdom,
    • Cardiff, , United Kingdom,
    • Exeter, , United Kingdom,
    • London, , United Kingdom,
    • Preston, , United Kingdom,

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 September 03, 2020