drugset
drugset / Trial / NCT03554005

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

NCT03554005 ↗

Phase 1 Completed 29 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
1997-12-29
Primary completion
2001-03-16
Completion
2001-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 0.75 ug/kg Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 3 ug/kg Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 4.5 ug/kg Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 6 ug/kg Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 7.5 ug/kg Subcutaneous
Background Acetaminophen Small molecule 500 mg Oral
Background Acetaminophen Small molecule 1000 mg Oral

Indications

neoplasm