Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059 AM2)(COMPLETED)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00604968
First received: January 21, 2008
Last updated: March 3, 2014
Last verified: February 2014
Results First Received: January 27, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Intervention: Drug: Caelyx (pegylated liposomal doxorubicin; SCH 200746)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
28 patients were screened and 25 were enrolled. All 25 patients enrolled received >=1 cycle of treatment with Caelyx. Per protocol, treatment was to continue until progression, unacceptable toxicity, or other reason for discontinuation of treatment - all subjects eventually discontinued treatment but were considered to have completed the study.

Reporting Groups
  Description
Caelyx Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).

Participant Flow:   Overall Study
    Caelyx  
STARTED     25  
COMPLETED     25 [1]
NOT COMPLETED     0  
[1] Due to the nature of study, all subjects receiving drug were considered to have completed.



  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.
No text entered.

Reporting Groups
  Description
Caelyx Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).

Baseline Measures
    Caelyx  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     25  
Age  
[units: years]
Mean ± Standard Deviation
  72.3  ± 5.0  
Gender  
[units: participants]
 
Female     25  
Male     0  



  Outcome Measures
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1.  Primary:   Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors {RECIST} or World Health Organization {WHO} Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).   [ Time Frame: Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). ]

2.  Secondary:   Number of Patients With Stable Disease (SD) as Best Response   [ Time Frame: Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). ]

3.  Secondary:   Number of Patients With Partial Response (PR) as Best Response   [ Time Frame: Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). ]

4.  Secondary:   Number of Patients With Progressive Disease (PD) as Best Response   [ Time Frame: Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). ]

5.  Secondary:   Number of Patients Requiring Dose Reduction   [ Time Frame: Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment). ]

6.  Secondary:   Time to Response   [ Time Frame: Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). ]

7.  Secondary:   Duration of Response   [ Time Frame: Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). ]

8.  Secondary:   Time to Progression   [ Time Frame: Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). ]

9.  Secondary:   Duration of Overall Survival   [ Time Frame: Time of treatment until death, up to the time that all participants ended treatment ]

10.  Secondary:   Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment   [ Time Frame: Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment). ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00604968     History of Changes
Other Study ID Numbers: P05059
Study First Received: January 21, 2008
Results First Received: January 27, 2011
Last Updated: March 3, 2014
Health Authority: Sweden: Medical Products Agency