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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: PEG Interferon Alfa-2b; Drug: Acetaminophen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03554005

C97349

C/l97-349 (Other Identifier)

MK-4031-009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Had a response of stable disease or better in PEG interferon alfa-2b base study C/I97-188 (MK-4031-006).
• Has a Performance Status of 0 (normal activity), 1 (symptoms, but fully ambulatory), or 2 (symptomatic, but in bed <50% of the day).
• Is enrolled within two weeks of completing their last dose of PEG Interferon alfa-2b on the previous study and has not have received any other therapy during this period.

Exclusion criteria

• Discontinued prior to completing PEG interferon alfa-2b base study C/I97-188 (MK-4031-006).
• Is pregnant or nursing.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 6 patient groups

PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW)

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: PEG Interferon Alfa-2b

PEG Interferon Alfa-2b 1.5 mcg/kg OW

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: PEG Interferon Alfa-2b

PEG Interferon Alfa-2b 3 mcg/kg OW

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: PEG Interferon Alfa-2b

PEG Interferon Alfa-2b 4.5 mcg/kg OW

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: PEG Interferon Alfa-2b

PEG Interferon Alfa-2b 6 mcg/kg OW

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: PEG Interferon Alfa-2b

PEG Interferon Alfa-2b 7.5 mcg/kg OW

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: PEG Interferon Alfa-2b