Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
This study has been terminated.
(A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology)
Information provided by:
First received: March 31, 2008
Last updated: January 6, 2011
Last verified: January 2011
The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma|
Resource links provided by NLM:
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab. [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Galiximab 500 mg/m2 IV once weekly times 4, followed by Galiximab 500 mg/m2 IV once monthly times 4 as an extended dosing regimen.
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