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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02854436
Recruitment Status : Active, not recruiting
First Posted : August 3, 2016
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Niraparib Phase 2

Detailed Description:
This is a multicenter and open-label (participants and researchers are aware of the treatment that participants are receiving) study that consists of 4 phases: a Prescreening Phase for biomarker evaluation only, a Screening Phase, a Treatment Phase (Cycle 1 Day 1 and will continue until the study drug is discontinued), a Follow-up Phase (every 3 months after end of treatment visit), and a Long-term Extension Phase (until participants no longer derive benefit from treatment or until further notification on different means of study treatment). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Actual Study Start Date : August 31, 2016
Estimated Primary Completion Date : January 11, 2021
Estimated Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.
Other Name: JNJ-64091742




Primary Outcome Measures :
  1. 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 ]
    ORR of soft tissue disease with no evidence of bone progression in participants with either biallelic Breast Cancer gene 1 (BRCA1) or Breast Cancer gene 2 (BRCA2) or germline BRCA. ORR in participants with measurable metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. ORR of soft tissue (visceral or nodal disease) as defined by RECIST 1.1 with no evidence of bone progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 4 years and 6 months ]
    ORR in participants with measurable metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. ORR of soft tissue (visceral or nodal disease) as defined by RECIST 1.1 with no evidence of bone progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria.

  2. 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) ]
    CTC response defined as CTC=0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (>) 0.

  3. Overall Survival (OS) [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
    OS is defined as time from enrollment to death from any cause.

  4. Radiographic Progression-Free Survival (rPFS) [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
    rPFS is defined as time from enrollment to radiographic progression or death.

  5. Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
    First PSA increase that is 25 percent (%) or greater and an absolute increase of 2 nanogram/milliliter (ng/mL) or more above the nadir.

  6. Time to Symptomatic Skeletal Event (SSE) [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
    Time to SSE: time from enrollment to first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.

  7. 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) ]
  8. 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) ]
    Duration of objective response is defined as time from complete response or partial response to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854436


Locations
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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
Umeå, 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
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02854436    
Other Study ID Numbers: CR108208
64091742PCR2001 ( Other Identifier: Janssen Research & Development, LLC )
2016-002057-38 ( EudraCT Number )
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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:
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Prostatic Neoplasms
Congenital Abnormalities
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents