Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079716
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2004-03-11
Brief Title:
Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma
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 Refractory or Recurrent Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2014-12
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:
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent
Detailed Description:
This is an open-label multi-dose single-arm phase I dose-escalation study to define the toxicity profile maximum tolerated dose MTD pharmacokinetics and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma
A minimum of three patients will be entered into each dose-level cohort All patients will receive a dose-loading schedule during the first two weeks The maximum weekly dose will be 16mgkg
A minimum of three patients will be entered into each dose-level cohort All patients will receive a dose-loading schedule during the first two weeks The maximum weekly dose will be 16mgkg
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