Trial document





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

  DRKS00009662

Trial Description

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Title

A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

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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 the study is to determine if advanced prostate cancer patient s that are
treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00009662
  •   2015/11/12
  •   2009/03/12
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2008-003314-97 
  •   NCT00861614  (ClinicalTrials.gov)
  •   CA184-043  (Bristol-Myers Squibb)
  •   2008-003314-97 
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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

- Overall survival; time frame: is assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase

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Secondary Outcome

- Compare progression free survival (PFS); time frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated
- Compare pain response; time frame: Assessed at screening, weeks 12, 18, 24, and at the End of Treatment visit
- Characterize safety profile; time frame: Assessed at each study visit while on treatment and for 70 days following the last dose of study drug

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Canada
  •   Chile
  •   Colombia
  •   Czech Republic
  •   Denmark
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Ireland
  •   Israel
  •   Italy
  •   Mexico
  •   Netherlands
  •   Peru
  •   Poland
  •   Puerto Rico
  •   Romania
  •   Russian Federation
  •   Spain
  •   United Kingdom
  •   United States
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2009/05/31
  •   796
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Advanced prostate cancer

- At least 1 bone metastasis

- Testosterone < 50 ng/dl

- Prior treatment with docetaxel

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Exclusion Criteria

- Brain metastasis

- Autoimmune disease

- Known HIV, Hep B, or Hep C infection

- More than 2 prior systemic anticancer regimens for prostate cancer

- Prior treatment on BMS CA180227 for prostate cancer

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Bristol-Myers Squibb
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
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    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • 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
  •   2012/11/01
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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 .
  •   2
  •   2015/11/10


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