Trials / Terminated
TerminatedNCT01636960
A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)
An Open-Label, Single-arm, Multicenter Phase I Study of SCH 54031 (Pegylated Interferon Alfa-2b) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (Protocol No. MK-4031 370 Also Known as SCH 54031, P08556)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a weekly basis is safe and tolerated.
Detailed description
The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PegIFN alfa-2b |
Timeline
- Start date
- 2012-12-25
- Primary completion
- 2014-03-26
- Completion
- 2015-11-04
- First posted
- 2012-07-10
- Last updated
- 2018-08-08
- Results posted
- 2015-02-11
Source: ClinicalTrials.gov record NCT01636960. Inclusion in this directory is not an endorsement.