Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-06 @ 12:23 PM
Study NCT ID:
NCT00623402
Status:
COMPLETED
Last Update Posted:
2011-01-12
First Post:
2008-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma
Sponsor:
University Hospital Schleswig-Holstein
Organization:
Study Overview
Official Title:
Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma: a Prospective Non-randomized, Multicenter Phase II Study
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SoraPeg
Brief 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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EudraCT 2007-001918-16 | None | None | View |