Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446095
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2007-03-08
Brief Title:
Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma
Sponsor:
Rigel Pharmaceuticals
Organization:
Rigel Pharmaceuticals
Study Overview
Official Title:
A Phase III Multi-Center Open Label Trial of the Safety and Efficacy of Fostamatinib in Patients With RelapsedRefractory B-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients B-cell lymphoma refractory diffuse nodular mantle other Phase I Two groups of 6 patients escalating dose tolerability- 28 days Phase II Three groups of 16 patients nodular diffuse large cell mantle cell plus others Oral bid dosing with highest tolerable dose until toxicity progression or withdrawal
Detailed Description:
This multicenter open-label study of fostamatinib 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 16 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 based on safety and anti-tumor activity will be determined
Phase II 48 additional patients 3 groups of 16 patients each will receive fostamatinib 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 CLL
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 16 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 based on safety and anti-tumor activity will be determined
Phase II 48 additional patients 3 groups of 16 patients each will receive fostamatinib 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 CLL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C-935788-009 | OTHER | Rigel Pharmaceuticals | None |