A Phase I/II Multi-Center, Open Label Trial of the Safety and Efficacy of Fostamatinib Disodium in Patients With Relapsed/Refractory B-Cell Lymphoma
This multicenter, open-label study of Fostamatinib Disodium will take place in two phases.
Phase I Two cohorts, of 6 patients each, will be sequentially assigned to receive 200 mg
(Cohort 1) and 250 mg (Cohort 2) PO bid of R788. Patients will be enrolled at 250 mg bid in
Cohort 2 only if < 1/6 patients in Cohort 1 experience dose-limiting toxicity (DLT) during
the initial 28-day treatment period. If 2 or more patients in Cohort 1 experience DLT during
the initial 28-day treatment period, patients in Cohort 2 will receive 150 mg PO bid.
Patients who do not experience DLT or disease progression may continue treatment at the
assigned dose level until disease progression, toxicity or withdrawal. Patients who
experience DLT may resume treatment at a lower dose level (dose will be decreased by 50 mg)
when the toxicity grade has decreased to ≤ 1. Once all patients in Phase I have completed 28
days of treatment, the optimal dose of Fostamatinib Disodium, based on safety and anti-tumor
activity, will be determined.
Phase II 48 additional patients, 3 groups of 16 patients each, will receive Fostamatinib
Disodium at the optimal biologic dose PO bid until tumor progression, limiting toxicity or
withdrawal. Group 1 will consist of patients with diffuse large B-cell lymphoma (DLBCL),
Group 2 will consist of patients with follicular lymphoma, and Group 3 will consist of
patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma,
marginal zone lymphomas, small lymphocytic lymphomas (SLL), and chronic lymphocytic leukemia
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (proportion of patients with best response of complete response (CR), unconfirmed response (CRu), partial response (PR)) for each group from Phase II
Jeffrey Skolnik, M.D.
United States: Food and Drug Administration
|Research Site||Anaheim, California|
|Research Site||Albany, Georgia|
|Research Site||Arlington Heights, Illinois|
|Research Site||Beverly, Massachusetts|
|Research Site||Alexandria, Minnesota|
|Research Site||Grand Island, Nebraska|
|Research Site||Albany, New York|
|Research Site||Akron, Ohio|