Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00743431
First received: August 26, 2008
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: May 21, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Ovarian Neoplasms
Intervention: Drug: Caelyx (Pegylated Lyposomal Doxorubicin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pegylated Lyposomal Doxorubicin 50 mg/m2 every 4 weeks for 6 cycles

Participant Flow:   Overall Study
    Pegylated Lyposomal Doxorubicin  
STARTED     224  
COMPLETED     98  
NOT COMPLETED     126  
Toxicity                 6  
Tumor progression                 56  
Withdrawal by Subject                 13  
Death                 9  
Reason for discontinuation not specified                 29  
No documentation available                 13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Pegylated Lyposomal Doxorubicin 50 mg/m2 every 4 weeks for 6 cycles

Baseline Measures
    Pegylated Lyposomal Doxorubicin  
Number of Participants  
[units: participants]
  224  
Age [1]
[units: years]
Mean ± Standard Deviation
  62.4  ± 10.95  
Gender  
[units: participants]
 
Female     224  
Male     0  
Region of Enrollment  
[units: participants]
 
Austria     224  
[1] Mean age was calculated for the Intent-to-Treat (ITT) population of 214.



  Outcome Measures

1.  Primary:   Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)   [ Time Frame: The observational program was conducted over a period of 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00743431     History of Changes
Other Study ID Numbers: P04085
Study First Received: August 26, 2008
Results First Received: May 21, 2010
Last Updated: July 15, 2014
Health Authority: Austria: Agency for Health and Food Safety