Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400764
Status:
TERMINATED
Last Update Posted:
2011-11-23
First Post:
2006-11-15
Brief Title:
A Study of Dulanermin in Combination With Rituximab in Subjects With Follicular and Other Low Grade CD20 Non-Hodgkins Lymphomas
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Phase IbII Open-Label Multicenter Study of the Safety Pharmacokinetics and Efficacy of Dulanermin Administered Intravenously in Combination With Rituximab to Subjects With Follicular and Other Low-Grade CD20 B-Cell Non-Hodgkins Lymphomas That Have Progressed Following Previous Rituximab Therapy
Status:
TERMINATED
Status Verified Date:
2011-11
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 Phase IbII open-label multicenter trial is designed to evaluate the safety pharmacokinetics and efficacy of dulanermin when combined with rituximab in subjects with follicular CD20 B-cell Non-Hodgkins Lymphoma NHL that has progressed following a response of 6 months duration to a prior rituximab-containing therapy The multicenter international randomized Phase II part of this study will commence only after the safety and available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the Sponsor and have been provided to participating investigators and the FDA
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