A Phase I, Open-Label, Dose Ranging Study to Assess the Safety and Distribution of Single or Multiple Doses of VB-111 in Patients With Advanced Metastatic Cancer
Seven Cohorts of dose escalating VB-111 were completed with a total of 33 subjects enrolled.
An additional cohort (Cohort 8) has been added to include multiple doses of VB-111 within
disease specific subgroups (Neuroendocrine Tumor, Renal Cell Carcinoma). Subjects will
receive a single infusion of VB-111 every 2 months until progression. 18-36 subjects are
expected to be enrolled at 3 centers.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST)
2 months
No
Pierre Triozzi, Dr.
Principal Investigator
The Cleveland Clinic
United States: Food and Drug Administration
GT-111001 (VB-111)
NCT00559117
November 2007
Name | Location |
---|---|
Cleveland Clinic | Cleveland, Ohio 44195 |
Dana Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02215 |
UTHSC- CTRC and Institute for Drug Development | San Antonio, Texas 78229 |