A Study of Pegylated Interferon Alfa-2b as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (P08556)
This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01636960
First received: July 5, 2012
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Melanoma |
Drug: PegIFN alfa-2b |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
MedlinePlus related topics:
Melanoma
Drug Information available for:
Interferon
Interferon Alfa-2a
Interferon Alfa-2b
Peginterferon Alfa-2b
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Incidence of dose-limiting toxicities (DLTs) [ Time Frame: From first dose through 8 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Participants receiving PegIFN alfa-2b |
Drug: PegIFN alfa-2b
PegIFN alfa-2b, subcutaneously, on Day 1 of each week at a dose of 6 μg/kg for 8 weeks and 3 μg/kg for up to an additional 252 weeks.
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Stage II or III melanoma
- Primary melanoma completely excised
- Full lymphadenectomy within 84 days prior to initiation of study treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
- Ocular melanoma or melanoma of the mucous membranes
- Evidence of distant or non-regional lymph node metastases
- In-transit melanoma
- Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy, radiotherapy or immunotherapy/vaccine for melanoma
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01636960 History of Changes |
| Other Study ID Numbers: | P08556, MK-4031-370 |
| Study First Received: | July 5, 2012 |
| Last Updated: | March 13, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Peginterferon alfa-2b Reaferon |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Adjuvants, Immunologic Alcohol Deterrents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013