Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103779
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2005-02-14
Brief Title:
A Safety Study of SGN-40 in Patients With Non-Hodgkins Lymphoma
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase I Multi-Dose Study of SGN-40 Anti-huCD40 mAb in Patients With Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multi-dose Phase I dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell lymphomas
Detailed Description:
A minimum of 3 patients will be entered into each dose-level cohort for 5 weeks A dose-escalation schema will be employed in cohorts The initial dose starts at 1 mgkg on Day 1 and 4 followed by 2mgkg on Day 8 Dose escalation will occur on weeks 3-5 with a maximum weekly dose of 8 mgkg Patients who meet criteria of at least partial response will be eligible for additional 4 weekly doses at highest dose tolerated
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