Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336986
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2006-06-14
Brief Title:
Efficacy Study of IL-21 to Treat Metastatic Melanoma
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
An Open-label Dose Escalation Safety and Tolerability Study of Recombinant Human Interleukin-21 Phase 1 Followed by an Open-label Treatment Study Phase 2a in Patients With Stage IV Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2023-08
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:
None
Brief Summary:
This trial is conducted in Oceania A phase 2a study to assess the effect on tumor size At least 14 to a maximum of 40 patients who have not previously received treatment for their stage IV disease will be treated for 6 weeks IL-21 will be administered intravenously
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None