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Trial record 66 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)

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ClinicalTrials.gov Identifier: NCT01636960
Recruitment Status : Terminated (The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.)
First Posted : July 10, 2012
Results First Posted : February 11, 2015
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Melanoma
Intervention Biological: PegIFN alfa-2b
Enrollment 9
Recruitment Details This study enrolled Japanese participants with Stage II or III malignant melanoma who had undergone surgical resection and lymphadenectomy.
Pre-assignment Details  
Arm/Group Title Participants Receiving PegIFN Alfa-2b
Hide Arm/Group Description Participants received 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).
Period Title: Induction Phase
Started 9
Completed 7 [1]
Not Completed 2
Reason Not Completed
Adverse Event             2
[1]
Participants continuing into Maintenance Phase
Period Title: Maintenance Phase
Started 7
Completed 0
Not Completed 7
Reason Not Completed
Continued drug after regulatory approval             3
Adverse Event             3
Progressive disease             1
Arm/Group Title Participants Receiving PegIFN Alfa-2b
Hide Arm/Group Description Participants received 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).
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
43.3  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
1.Primary Outcome
Title Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase
Hide Description A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.
Time Frame From first dose to end of induction phase; up to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the induction phase of the study
Arm/Group Title Participants Receiving PegIFN Alfa-2b
Hide Arm/Group Description:
Participants received 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).
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
2
2.Secondary Outcome
Title Safety: Number of Participants Experiencing Adverse Events (AEs)
Hide Description An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time Frame From first dose through follow-up; up to 265 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Participants Receiving PegIFN Alfa-2b
Hide Arm/Group Description:
Participants received 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).
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
9
3.Secondary Outcome
Title Number of Participants Discontinuing Study Drug Because of AEs
Hide Description An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time Frame From first dose to last dose of treatment; up to 260 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one dose of study drug.
Arm/Group Title Participants Receiving PegIFN Alfa-2b
Hide Arm/Group Description:
Participants received 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).
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
5
Time Frame From first dose through follow-up; up to 265 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants Receiving PegIFN Alfa-2b
Hide Arm/Group Description Participants received 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).
All-Cause Mortality
Participants Receiving PegIFN Alfa-2b
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Participants Receiving PegIFN Alfa-2b
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participants Receiving PegIFN Alfa-2b
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  2/9 (22.22%)  5
Ear and labyrinth disorders   
Tinnitus  1  1/9 (11.11%)  1
Vertigo positional  1  1/9 (11.11%)  1
Eye disorders   
Eye pain  1  1/9 (11.11%)  3
Photophobia  1  1/9 (11.11%)  1
Punctate keratitis  1  2/9 (22.22%)  2
Retinopathy  1  2/9 (22.22%)  2
Vitreous floaters  1  1/9 (11.11%)  1
Chalazion  1  1/9 (11.11%)  3
Ocular discomfort  1  1/9 (11.11%)  1
Gastrointestinal disorders   
Abdominal pain upper  1  1/9 (11.11%)  1
Aphthous stomatitis  1  1/9 (11.11%)  1
Constipation  1  3/9 (33.33%)  3
Diarrhoea  1  3/9 (33.33%)  5
Dyspepsia  1  1/9 (11.11%)  1
Nausea  1  6/9 (66.67%)  12
Periodontal disease  1  1/9 (11.11%)  2
Stomatitis  1  3/9 (33.33%)  3
Vomiting  1  2/9 (22.22%)  2
Abdominal discomfort  1  1/9 (11.11%)  1
Gastritis  1  1/9 (11.11%)  1
General disorders   
Chills  1  6/9 (66.67%)  13
Fatigue  1  5/9 (55.56%)  7
Injection site erythema  1  3/9 (33.33%)  3
Injection site extravasation  1  1/9 (11.11%)  1
Injection site pruritus  1  3/9 (33.33%)  3
Injection site reaction  1  6/9 (66.67%)  29
Malaise  1  6/9 (66.67%)  23
Oedema peripheral  1  1/9 (11.11%)  1
Pyrexia  1  9/9 (100.00%)  33
Influenza like illness  1  2/9 (22.22%)  2
Injection site joint pain  1  1/9 (11.11%)  1
Infections and infestations   
Conjunctivitis  1  2/9 (22.22%)  3
Adenoiditis  1  1/9 (11.11%)  1
Cystitis  1  1/9 (11.11%)  2
Gastroenteritis bacterial  1  1/9 (11.11%)  1
Gingivitis  1  1/9 (11.11%)  1
Pericoronitis  1  1/9 (11.11%)  1
Upper respiratory tract infection  1  4/9 (44.44%)  8
Skin infection  1  1/9 (11.11%)  1
Injury, poisoning and procedural complications   
Accidental overdose  1  1/9 (11.11%)  1
Laceration  1  1/9 (11.11%)  1
Procedural pain  1  1/9 (11.11%)  2
Investigations   
Alanine aminotransferase increased  1  8/9 (88.89%)  8
Aspartate aminotransferase increased  1  8/9 (88.89%)  11
Gamma-glutamyltransferase increased  1  2/9 (22.22%)  2
Lymphocyte count decreased  1  2/9 (22.22%)  6
Neutrophil count decreased  1  9/9 (100.00%)  21
Platelet count decreased  1  5/9 (55.56%)  7
Weight decreased  1  5/9 (55.56%)  6
White blood cell count decreased  1  9/9 (100.00%)  19
Blood lactate dehydrogenase increased  1  1/9 (11.11%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  4/9 (44.44%)  9
Glucose tolerance impaired  1  1/9 (11.11%)  1
Hyperglycaemia  1  2/9 (22.22%)  3
Hypertriglyceridaemia  1  4/9 (44.44%)  9
Hypoalbuminaemia  1  2/9 (22.22%)  4
Hypocalcaemia  1  2/9 (22.22%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  9/9 (100.00%)  20
Myalgia  1  6/9 (66.67%)  10
Back pain  1  1/9 (11.11%)  1
Limb discomfort  1  1/9 (11.11%)  1
Pain in extremity  1  1/9 (11.11%)  1
Nervous system disorders   
Dizziness  1  2/9 (22.22%)  3
Dysgeusia  1  1/9 (11.11%)  2
Headache  1  5/9 (55.56%)  63
Hypoaesthesia  1  1/9 (11.11%)  1
Loss of consciousness  1  1/9 (11.11%)  1
Quadriplegia  1  1/9 (11.11%)  1
Psychiatric disorders   
Insomnia  1  2/9 (22.22%)  2
Renal and urinary disorders   
Proteinuria  1  1/9 (11.11%)  1
Urinary tract disorder  1  1/9 (11.11%)  1
Reproductive system and breast disorders   
Dysmenorrhoea  1  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/9 (22.22%)  2
Epistaxis  1  1/9 (11.11%)  1
Oropharyngeal pain  1  2/9 (22.22%)  2
Pharyngeal inflammation  1  1/9 (11.11%)  1
Interstitial lung disease  1  1/9 (11.11%)  1
Pleuritic pain  1  1/9 (11.11%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  4/9 (44.44%)  5
Drug eruption  1  1/9 (11.11%)  1
Dry skin  1  1/9 (11.11%)  1
Pruritus  1  1/9 (11.11%)  3
Rash  1  1/9 (11.11%)  1
Rash maculo-papular  1  3/9 (33.33%)  4
Seborrhoeic dermatitis  1  1/9 (11.11%)  1
Urticaria  1  1/9 (11.11%)  1
Dermatitis acneiform  1  1/9 (11.11%)  2
Dermatitis contact  1  1/9 (11.11%)  2
Rash papular  1  1/9 (11.11%)  1
Skin disorder  1  1/9 (11.11%)  1
Skin hypopigmentation  1  1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.
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 Investigator agrees not to publish or publicly present any interim results of the trial without prior written consent of the Sponsor. The Investigator further agrees to provide review copies of abstracts or manuscripts (both oral and textual including transmission through any electronic medium). No publication or manuscript shall contain any trade secret information of the Sponsor or any proprietary or confidential information of the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
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 )
First Submitted: July 5, 2012
First Posted: July 10, 2012
Results First Submitted: January 26, 2015
Results First Posted: February 11, 2015
Last Update Posted: August 8, 2018