Clinical trial · Interventional
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
NCT03554005CI-TRIAL-00039478completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| PEG Interferon Alfa-2b | Drug | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW)
- 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.
- interventionNames
- Drug: PEG Interferon Alfa-2b
- Drug: Acetaminophen
- type
- EXPERIMENTAL
- label
- PEG Interferon Alfa-2b 1.5 mcg/kg OW
- 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.
- interventionNames
- Drug: PEG Interferon Alfa-2b
- Drug: Acetaminophen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.