Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005402

Trial Description

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Title

Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer

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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 determine if patients with metastatic prostate cancer who
have not received chemotherapy live longer when treated with ipilimumab than those treated
with a placebo

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00005402
  •   2013/11/20
  •   2010/01/26
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2009-016217-23 
  •   NCT01057810  (ClinicalTrials.gov)
  •   CA184-095  (Bristol-Myers Squibb)
  •   2009-016217-23 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Ipilimumab
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- To compare overall survival (OS) of subjects, defined as the time from the date of randomization until the date of death. For those subjects who have not died OS will be censored at the last date the subject was known to be alive; time frame: Assessed at each study visit while on treatment and every 12 weeks during follow-up

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Secondary Outcome

- Compare Progression Free Survival (PFS) by collecting tumor assessments every 12 weeks until protocol defined progression or initiation of subsequent therapy for prostate cancer; time frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer
- Compare time to pain progression by collection of a Patient Pain Diary prior to each treatment visit and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer; time frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer
- Compare time to subsequent non-hormonal systemic therapy by collection of subsequent prostate cancer therapies during follow up; time frame: Every 12 weeks during follow up until initiation of subequent non-hormonal systemic therapy for prostate cancer
- Characterize Safety Profile by collection of adverse event information and review of laboratory values at every study visit; time frame: Continuously throughout study and during follow up until all toxicities have resolved, returned to baseline or been deemed irreversible

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Brazil
  •   Canada
  •   Chile
  •   Colombia
  •   Czech Republic
  •   Denmark
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Italy
  •   Mexico
  •   Netherlands
  •   Norway
  •   Poland
  •   Puerto Rico
  •   Romania
  •   Spain
  •   Sweden
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
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Recruitment

  •   [---]*
  •   2010/05/31
  •   600
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Metastatic prostate cancer

- Asymptomatic or minimally symptomatic

- Progression during hormonal therapy

- ECOG Performance Status 0-1

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Exclusion Criteria

- Liver, lung or brain metastases

- Prior immunotherapy or chemotherapy for metastatic prostate cancer

- Autoimmune disease

- HIV, Hepatitis B, or Hepatitis C infection

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Addresses

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    • Bristol-Myers Squibb
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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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 complete, follow-up complete
  •   2015/07/01
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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 .
  •   5
  •   2016/01/14


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