Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00011169

Trial Description

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Title

A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00011169
  •   2016/10/17
  •   2016/08/01
  •   no
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Secondary IDs

  •   2016-002057-38 
  •   NCT02854436  (ClinicalTrials.gov)
  •   CR108208  (Janssen Research & Development, LLC)
  •   64091742PCR2001 
  •   2016-002057-38 
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Health Condition or Problem studied

  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Niraparib
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- 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 (%).

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Secondary Outcome

- 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.

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Countries of Recruitment

  •   Australia
  •   Belgium
  •   Canada
  •   Denmark
  •   France
  •   Germany
  •   Netherlands
  •   Spain
  •   Sweden
  •   United States
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Locations of Recruitment

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Recruitment

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  •   2016/08/31
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Histologically confirmed prostate cancer

- At least 1 line of taxane-based chemotherapy

- At least 1 line of Androgen Receptor (AR) targeted therapy

- Biomarker positive sample for deoxyribonucleic acid (DNA) repair anomalies

- Progression of metastatic prostate cancer in the setting of castrate levels of
testosterone less than equal to (<=)50 nanogram per deciliter (ng/dL) on a
gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at
study entry defined as having one or more of the following: (a) Prostate Specific
Antigen (PSA) progression defined by a minimum of 2 rising PSA levels with an
interval of >=1 week between each determination. The PSA level at the screening visit
should be >=2 microgram per liters (mcg/L) [2 ng/mL], (b) Radiographic progression of
soft tissue or bone disease by Prostate Cancer Working Group 3 (PCWG3) criteria

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Exclusion Criteria

- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP)
inhibitor

- Prior platinum-based chemotherapy

- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid
leukemia (AML)

- Known symptomatic or impending cord compression

- Known symptomatic uncontrolled brain or leptomeningeal metastases (Day 1)

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Addresses

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    • Janssen Research & Development, LLC
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    • Janssen Research & Development, LLC
    • Janssen Research & Development, LLC Clinical Trial 
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    • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/10/05


* This entry means the parameter is not applicable or has not been set.