A Study of MORAb-009 in Patients With Solid Tumor
This study has been completed.
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: November 23, 2009
Last updated: December 3, 2012
Last verified: December 2012
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of MORAb-009 in Patients With Solid Tumor|
Resource links provided by NLM:
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- To investigate dose-limiting toxicity and estimate maximum tolerated dose. [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response. [ Time Frame: During Study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.
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