Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006473

Trial Description

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Title

A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study

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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 collect follow-up safety data from participants in completed
abiraterone acetate studies for a maximum duration of 6 years.

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Brief Summary in Scientific Language

This is a nonrandomized (individuals will not be assigned by chance to study treatments),
open-label (individuals will know the identity of study treatments), long-term safety
follow-up study of abiraterone acetate in approximately 300 patients from other completed
abiraterone acetate clinical studies. Patients must have received at least 3 months of
treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator
assessment, may benefit from continued treatment. This study will consist of a screening
period followed by open-label treatment of continued abiraterone acetate access. The
patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing
regimen they were receiving in the previous abiraterone acetate clinical study until the
investigator determines that the patient is no longer receiving benefit or the sponsor
terminates the study. Patients can be withdrawn from the study if an alternative access (eg,
patient-assistance program or commercial source of abiraterone acetate) is available and
feasible. Each cycle of treatment will be 28 days. Investigators will monitor and assess the
patients for response to treatment or progression according to routine practice or as
clinically indicated to determine whether continued treatment with abiraterone acetate is
warranted. No efficacy data are being collected. Safety will be monitored throughout the
study for a maximum duration of 6 years. End-of-study assessments will be performed at least
30 days after the last dose of abiraterone or upon early withdrawal.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006473
  •   2014/09/19
  •   2012/01/23
  •   no
  •   [---]*
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Secondary IDs

  •   2011-005243-28 
  •   NCT01517802  (ClinicalTrials.gov)
  •   CR100797  (Janssen Research & Development, LLC)
  •   212082PCR3010 
  •   2011-005243-28 
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Health Condition or Problem studied

  •   Metastatic Castration-resistant Prostate Cancer
  •   Metastatic Breast Cancer
  •   C61 -  Malignant neoplasm of prostate
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Drug: Abiraterone acetate
  •   Drug: Prednisone
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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)
  •   III
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Primary Outcome

- The number of participants affected by a serious adverse event; time frame: Up to 30 days after the last dose of study drug

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   United States
  •   Australia
  •   Belgium
  •   Germany
  •   Spain
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/03/31
  •   300
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Currently participating in an abiraterone acetate clinical study considered complete
and had received at least 3 months of treatment with abiraterone acetate tablets.

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Exclusion Criteria

- Medical conditions that require hospitalization.

- Any condition or situation which, in the opinion of the investigator, may put the
patient at significant risk, may confound the study results, or may interfere
significantly with the patient's participation in the study.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Janssen Research & Development, LLC
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    •   [---]*
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    •   [---]*
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    • Janssen Research & Development, LLC
    • Janssen Research & Development, LLC Clinical Trial 
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    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • Janssen Research & Development, LLC
    • Janssen Research & Development, LLC Clinical Trial 
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    •   [---]*
    •   [---]*
    •   [---]*
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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 continuing
  •   [---]*
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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 .
  •   4
  •   2016/01/14


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