Phase II, Multicenter, Simon Two-Stage Study of Fostamatinib Disodium in Patients With Relapsed or Refractory T-Cell Lymphoma
Up to 61 patients (male and female) meeting the inclusion and exclusion criteria will be
enrolled into this trial in two stages. All enrolled patients will be treated with R788 at
200 mg PO bid until disease progression. In the initial stage of the study, a total of 19
patients will be enrolled and treated with Fostamatinib Disodium. Should at least 4 patients
exhibit a response at Week 8 or later of the study, the second stage of 36 patients will
open to enrollment. Efficacy will be assessed by CT and PET scans (when indicated) and
physical exam at baseline, and CT scans and physical exam of all disease-involved areas
every 8 weeks until progression. Safety will be assessed by periodic physical exams,
clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30
days following last study drug treatment. Blood samples for PK assessment will be obtained
from all patients enrolled in Stage 1 at protocol-defined intervals. Patients with
accessible tumor tissue will be asked to undergo a biopsy for a fresh tissue sample for
assessment of Syk activity in tumor tissue. Archived tissue samples from the initial
diagnostic biopsy and the most recent biopsy for lymphoma will be obtained in the event a
fresh tumor biopsy cannot be obtained. Patients who have accessible tumor tissue will be
asked to consent to a second tumor biopsy at Week 8, to assess the impact of Fostamatinib
Disodium treatment on the activity of Syk and its downstream markers. All baseline fresh or
archived tumor tissue samples will undergo central pathology review to confirm the diagnosis
of TCL.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary efficacy endpoint for this study is the overall response rate (ORR) [proportion of patients with best response of complete response (CR) or partial response (PR)].
8 weeks
Yes
Jeffrey Skolnik, MD
Study Director
AstraZeneca
United States: Food and Drug Administration
D4300C00024
NCT00798096
March 2009
April 2010
Name | Location |
---|---|
Research Site | Anaheim, California |
Research Site | Albany, Georgia |
Research Site | Beverly, Massachusetts |
Research Site | Alexandria, Minnesota |
Research Site | Grand Island, Nebraska |
Research Site | Albany, New York |
Research Site | Abilene, Texas |