Phase 1
Completed N=29
Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)
Neoplasms
Source: ClinicalTrials.gov NCT03554005 ↗
Enrolled (actual)
29
Serious AEs
17.2%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event — 1; 2; 1; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event |
1; 2; 1; 2; 11; 11 | — |
| PRIMARY Number of Participants Who Discontinued Treatment Due to an Adverse Event |
0; 0; 0; 0; 0; 3 | — |
| SECONDARY Best Objective Response |
0; 0; 1; 0; 3; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03554005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.