Antipyretics

Analgesics

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Acetaminophen

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Analgesics, Non-Narcotic

Immunologic Factors

Participants receive PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.

Participants receive PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.

Participants receive PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.

Participants receive PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.

Participants receive PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.

Participants receive PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.

Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.

PEG Interferon Alfa-2b

Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.

Medical Director

This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary purpose is to assess the safety and tolerability of extended administration of polyethylene glycol (PEG) interferon alfa-2b in participants with solid tumors.

Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)

Open-Label Extended Administration of SCH 54031 (PEG Interferon Alfa-2b/PEG Intron) in Subjects With Solid Tumors

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Best Objective Response data were based on World Health Organization (WHO) criteria and included four categories. Complete Response (CR) was the disappearance of all clinically detectable malignant disease. Partial Response (PR) was a decrease of ≥50% of the sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; and a decrease of ≥50% in sum of largest diameters of all unidimensionally measure lesions. Stable Disease (SD) was a \<50% decrease or \<25% increase in sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; or a \<50% decrease or \<25% increase in sum of diameters of all unidimensionally measurable lesions. In addition, no new lesions appeared. Progressive Disease (PD) was a ≥25% increase in size of at least one bidimensionally or unidimensionally measurable lesion or appearance of new lesion. Occurrence of pleural effusion or ascites was also considered PD if substantiated by positive cytology.

Merck Sharp & Dohme LLC

Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

PEG Interferon Alfa-2b 0.75 mcg/kg OW

Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

PEG Interferon Alfa-2b 1.5 mcg/kg OW

Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

PEG Interferon Alfa-2b 3 mcg/kg OW

Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

PEG Interferon Alfa-2b 4.5 mcg/kg OW

Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

PEG Interferon Alfa-2b 6 mcg/kg OW

Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

PEG Interferon Alfa-2b 7.5 mcg/kg OW

Total

Age, Continuous

Sex: Female, Male

Adverse Event (AE) Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 10.0.

Senior Vice President, Global Clinical Development

Number of Participants Who Experienced an Adverse Event

Number of Participants Who Discontinued Treatment Due to an Adverse Event

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Not Evaluated

Best Objective Response

Participants received PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Spots Global Cancer Trial Database for Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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