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

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ClinicalTrials.gov Identifier: NCT02854436
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 3, 2016
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE August 31, 2016
Estimated Primary Completion Date February 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
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 in Breast Cancer gene 1 (BRCA1) or gene 2 (BRCA2). ORR is defined as proportion of participants with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Response Rate (RR) [ Time Frame: From enrollment to completion of study (approximately 3 years and 2 months) ]
RR is defined as: objective response, or conversion of circulating tumor cells, or prostate specific antigen (PSA) decline of >=50 percent (%).
Change History Complete list of historical versions of study NCT02854436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
  • Objective Response Rate (ORR) [ Time Frame: Approximately up to 3 years and 2 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.
  • 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) ]
    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.
  • Overall Survival (OS) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    OS is defined as time from enrollment to death from any cause.
  • Radiographic Progression-Free Survival (rPFS) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    rPFS is defined as time from enrollment to radiographic progression or death.
  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 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.
  • Time to Symptomatic Skeletal Event (SSE) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    Time to SSE: time from enrollment to first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.
  • 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) ]
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Overall Survival (OS) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    OS is defined as time from enrollment to death from any cause.
  • Radiographic Progression-Free Survival (rPFS) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    rPFS is defined as time from enrollment to radiographic progression or death.
  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    Time to PSA progression is defined as the time to first PSA increase that is 25% or greater and an absolute increase of 2 nanogram/milliliter (ng/mL) or more above the nadir.
  • Time to Symptomatic Skeletal Event (SSE) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    Time to SSE: time from enrollment to first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.
  • 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) ]
  • 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) ]
    Duration of objective response will be assessed in participants who achieved a CR or PR. The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Official Title  ICMJE A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
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.
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), and a Follow-up Phase (every 3 months after end of treatment visit). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE Drug: Niraparib
Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily.
Other Name: JNJ-64091742
Study Arms  ICMJE Experimental: Niraparib
Participants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily.
Intervention: Drug: Niraparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
301
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
100
Estimated Study Completion Date  ICMJE June 21, 2020
Estimated Primary Completion Date February 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Denmark,   France,   Israel,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT02854436
Other Study ID Numbers  ICMJE CR108208
64091742PCR2001 ( Other Identifier: Janssen Research & Development, LLC )
2016-002057-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP