Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19
patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients
exhibit a response at Week 8 or later in the study. All enrolled patients will be treated
with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor
measurements using CT and PET (when indicated) scans and physical exam at baseline, and 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.