NCT00623402

Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma

Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma: a Prospective Non-randomized, Multicenter Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of a combined treatment with Sorafenib (Nexavar®) and pegylated interferon-α-2b (PegIntron®) in patients with malignant melanoma in stage IV.

Detailed description

This is a a prospective non-randomized, multicenter Phase II Study to evaluate the efficacy and safety of a combined treatment with Sorafenib (Nexavar®) and pegylated interferon-α-2b (PegIntron®) in patients with malignant melanoma in stage IV. The investigators will determine disease control rate (CR,PR,SD) after 8 weeks of treatment with pegylated interferon- α-2b (3 µg/kg body weight s.c. once a week) combined with Sorafenib 2x 400 mg (2 tablets orally, twice daily)

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Sorafenib	2x 400 mg orally per day (4 tablets)
DRUG	pegylated interferon α-2b	3 µg/kg body weight s.c. once a week

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-10-01
• First posted: 2008-02-26
• Last updated: 2011-01-12

Locations

10 sites across 1 country: Germany