Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051597
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2003-01-13
Brief Title:
A SafetyEfficacy Study of SGN-30 Antibody in Patients With Refractory or Recurrent CD30 Hematologic Malignancies
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase III Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30 Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate a multi-dose regimen of SGN-30 a novel chimeric monoclonal antibody mAb in patients with refractory or recurrent CD30 hematologic malignancies
This is a single-arm open-label phase III study designed to define the toxicity profile pharmacokinetic PK profile and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30 hematologic malignancies The phase I study will be a modified dose escalation of SGN-30 Based on preclinical pharmacology and toxicokinetics TK and the first use in human single-dose phase I study SGN-30 will be administered on a weekly schedule An initial dose of 2 mgkg will escalate until the maximum tolerated dose MTD has been reached or until a weekly dose of 12 mgkg is achieved
This is a single-arm open-label phase III study designed to define the toxicity profile pharmacokinetic PK profile and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30 hematologic malignancies The phase I study will be a modified dose escalation of SGN-30 Based on preclinical pharmacology and toxicokinetics TK and the first use in human single-dose phase I study SGN-30 will be administered on a weekly schedule An initial dose of 2 mgkg will escalate until the maximum tolerated dose MTD has been reached or until a weekly dose of 12 mgkg is achieved
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