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A Study of Pegylated Interferon Alfa-2b as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (P08556)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01636960
First received: July 5, 2012
Last updated: June 9, 2016
Last verified: June 2016
Results First Received: January 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Intervention: Biological: PegIFN alfa-2b

  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
This study enrolled Japanese participants with Stage II or III malignant melanoma who had undergone surgical resection and lymphadenectomy.

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
Participants Receiving PegIFN Alfa-2b Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).

Participant Flow for 2 periods

Period 1:   Induction Phase
    Participants Receiving PegIFN Alfa-2b  
STARTED     9  
COMPLETED     7 [1]
NOT COMPLETED     2  
Adverse Event                 2  
[1] Participants continuing into Maintenance Phase

Period 2:   Maintenance Phase
    Participants Receiving PegIFN Alfa-2b  
STARTED     7  
COMPLETED     0  
NOT COMPLETED     7  
Participants still receiving drug                 5  
Adverse Event                 2  



  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
Participants Receiving PegIFN Alfa-2b Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).

Baseline Measures
    Participants Receiving PegIFN Alfa-2b  
Number of Participants  
[units: participants]
  9  
Age  
[units: Years]
Mean (Standard Deviation)
  43.3  (13.7)  
Gender  
[units: Participants]
 
Female     4  
Male     5  



  Outcome Measures
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1.  Primary:   Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase   [ Time Frame: Up to 8 weeks ]

2.  Secondary:   Safety: Number of Participants Experiencing Adverse Events (AEs)   [ Time Frame: Up to 1 year (to be updated as data collection continues) ]

3.  Secondary:   Number of Participants Discontinuing Study Drug Because of AEs   [ Time Frame: Up to 1 year (to be updated as data collection continues) ]


  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 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.


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: NCT01636960     History of Changes
Other Study ID Numbers: P08556
MK-4031-370 ( Other Identifier: Merck protocol number )
132228 ( Registry Identifier: JAPIC-CTI )
Study First Received: July 5, 2012
Results First Received: January 26, 2015
Last Updated: June 9, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency