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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

Phase 1/Phase 2
18 Years
80 Years
Not Enrolling

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Trial Information

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

Inclusion Criteria:

1. Patients must be > 18 years old.

2. Patients must be willing and able to give written informed consent by signing an
IRB-approved Informed Consent Form prior to admission to this study and must fully
understand the requirements of the study and be willing to comply with all study
visits and assessments.

3. Patients with relapsed/refractory B-cell malignancy, (DLBCL, follicular lymphoma,
mantle cell lymphoma, MALT lymphoma, marginal zone lymphoma, CLL or SLL), who have
failed at least one prior treatment regimen and for whom no standard therapy exists;
patients who are intolerant of standard therapy or who are not candidates for
available standard therapy may also be included.

4. Patients must have measurable disease.

5. Patients may be male or female. Men, if sexually active, must agree to use at least
one medically acceptable form of birth control for the duration of the study and for
30 days thereafter. Sexually active women of childbearing potential must have a
negative serum pregnancy test, and agree to use two independent methods of birth
control for the duration of the study and for 30 days thereafter.

Exclusion Criteria:

1. Patients with T-cell lymphoma or primary CNS lymphoma

2. Patients with a history of malignancy other than lymphoma, except basal cell
carcinoma of the skin and in situ cervical carcinoma, if < 2 years since curative

3. Chemotherapy within 4 weeks of Day 1 of treatment (6 weeks for mitomycin C and

4. Antibody therapy or lymphoma vaccine therapy within 6 weeks of Day 1

5. Radiotherapy within 2 weeks of Day 1, 4 weeks if to marrow-bearing sites (sternum,

6. Any other investigational therapy within 4 weeks of Day 1

7. Significant gastrointestinal disease (Crohn's or ulcerative colitis) or major gastric
or small bowel surgery

8. Difficulty swallowing or malabsorption

9. Patients with bone marrow impairment: Hgb < 9.0 g/dL; ANC < 1500/μL; platelets <

10. Patients with impairment of renal function: creatinine > 2.0 g/dL

11. Patients with abnormal liver function: AST/ALT > 3x ULN (up to 5x ULN with liver
involvement); bilirubin > 1.5 mg/dL

12. Patients who have been treated with a CYP3A4 inducer/inhibitor within 1 week prior to
Day 1 or who are expected to require treatment with CYP3A4 inducer/inhibitor during
the course of the study (Appendix IV)

13. Patients with Karnofsky performance status < 60% (Appendix I)

14. Patients whose life expectancy is < 3 months

15. Patients who are known to be HIV positive

16. Patients who have a history of any other significant medical or physical condition
that might impair the patient's well being or preclude full participation in the

17. Pregnant or nursing females

18. Patients receiving systemic or chronic inhaled steroids, with the exception of
intermittent dexamethasone for the treatment of emesis or intermittent steroid
inhalers for exacerbations of asthma

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Jeffrey Skolnik, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

October 2010

Related Keywords:

  • Lymphoma
  • DLCL
  • Nodular lymphoma
  • Mantle cell lymphoma
  • Syk kinase
  • Lymphoma
  • Lymphoma, B-Cell



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