A Study in Subjects With Recurrent Malignant Glioma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: June 2, 2010
Last updated: November 5, 2012
Last verified: November 2012
An open-label phase 2, multicenter study in subjects with recurrent malignant glioma.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Three-Cohort, Phase 2 Study of E7080 in Subjects With Recurrent Malignant Glioma|
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- The primary outcome of 6-month progression free survival will be estimated from PFS Kaplan-Meier (K-M) product-limit estimate of progression free survival. [ Time Frame: 6-month progression-free survival ] [ Designated as safety issue: No ]Subjects will remain on study until they have objective progression of disease, development of unacceptable toxicity or withdrawl from continuation of treatment
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: Cohort 1||
Will assess subjects with recurrent GBM who are bevacizumab-naïve. Approximately 98 subjects accrued in Cohort 1 will be randomized in a 1:1 ratio to receive 24 mg E7080 (Arm A), orally once daily or bevacizumab (Arm B) at a dose of 10 mg/kg intravenously every 2 weeks in 28-day cycles. A subject in Cohort 1 with disease progression following bevacizumab treatment may be enrolled in Cohort 3. The subject must be assigned a new Subject Identification Number.
|Experimental: Cohort 2||
Will assess subjects with recurrent grade 3 malignant glioma who are bevacizumab-naïve. Approximately 40 subjects in Cohort 2 will be treated with 24 mg E7080 orally, once daily in 28-day cycles.
|Experimental: Cohort 3||
Will assess subjects with recurrent GBM who have disease progression following prior bevacizumab treatment. Approximately 32 subjects will receive 24 mg E7080 orally, once daily in 28-day cycles in Cohort 3. Treatment will continue until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation of E7080 development by the Sponsor. The primary endpoint of each cohort is 6-month progression-free survival rate. The assessment will be made separately among the 3 cohorts.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137604
|United States, Florida|
|Tampa, Florida, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, North Carolina|
|Durham, North Carolina, United States|
Sponsors and Collaborators
|Study Director:||Eisai Medical Services||Eisai Inc.|