CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
PEG Interferon Alfa-2b +1 moredrug
Likely dose
PEG Interferon Alfa-2b 0.75 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03554005
NCT03554005Phase 1Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Jun 12, 2018·Updated Jul 15, 2019

In Brief

A Phase 1 clinical trial evaluating PEG Interferon Alfa-2b and Acetaminophen for Neoplasms. Completed, enrolled 29 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2018
Enrollment StartDec 29, 1997
Primary CompletionMar 16, 2001
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.1 years ago

Interventions

PEG Interferon Alfa-2bdrug

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.

Acetaminophendrug

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.