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

NCT03554005 | Completed Phase 1 Results

• 3 other identifiers: C97349MK-4031-009C/l97-349
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced an Adverse Event

  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.

  Up to 42 Weeks

• Number of Participants Who Discontinued Treatment Due to an Adverse Event

  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.

  Up to 40 Weeks

Secondary Outcomes (1)

• Best Objective Response

  Up to 40 Weeks

Study Arms (6)

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

EXPERIMENTAL

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.

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

PEG Interferon Alfa-2b 1.5 mcg/kg OW

EXPERIMENTAL

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.

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

PEG Interferon Alfa-2b 3 mcg/kg OW

EXPERIMENTAL

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.

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

PEG Interferon Alfa-2b 4.5 mcg/kg OW

EXPERIMENTAL

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.

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

PEG Interferon Alfa-2b 6 mcg/kg OW

EXPERIMENTAL

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.

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

PEG Interferon Alfa-2b 7.5 mcg/kg OW

EXPERIMENTAL

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.

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

Interventions

PEG Interferon Alfa-2b DRUG

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.

Also known as: MK-4031, SCH 54031, PEG Intron®

PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW); PEG Interferon Alfa-2b 1.5 mcg/kg OW; PEG Interferon Alfa-2b 3 mcg/kg OW; PEG Interferon Alfa-2b 4.5 mcg/kg OW; PEG Interferon Alfa-2b 6 mcg/kg OW; PEG Interferon Alfa-2b 7.5 mcg/kg OW

Acetaminophen DRUG

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.

Also known as: Tylenol®

PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW); PEG Interferon Alfa-2b 1.5 mcg/kg OW; PEG Interferon Alfa-2b 3 mcg/kg OW; PEG Interferon Alfa-2b 4.5 mcg/kg OW; PEG Interferon Alfa-2b 6 mcg/kg OW; PEG Interferon Alfa-2b 7.5 mcg/kg OW

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Neoplasms

Interventions

peginterferon alfa-2b; Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 12, 2018
• Study Start: December 29, 1997
• Primary Completion: March 16, 2001
• Study Completion: March 16, 2001
• Last Updated: July 15, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-07