Efficacy and Safety study of fostamatinib tablets to treat B-cell Lymphoma

Study identifier:D4300C00023

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I/II Multi-Center, Open Label Trial of the Safety and Efficacy of Fostamatinib in Patients With Relapsed/Refractory B-Cell Lymphoma

Medical condition

Lymphoma

Phase

Phase 1/2

Healthy volunteers

Study drug

fostamatinib

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 01 Apr 2007

Primary Completion Date: 01 Apr 2010

Study Completion Date: 01 Oct 2010

Study design

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

Verification:

Verified 01 Mar 2015 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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 treatment
3) Chemotherapy within 4 weeks of Day 1 of treatment (6 weeks for mitomycin C and nitrosoureas)
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, pelvis)
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 < 75,000/μL
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 study
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

No locations available

Arms	Assigned Interventions
Experimental: fostamatinib	Drug: fostamatinib 200 mg PO BID Other Name: R935788, R788, fostamatinib

Documents available

D4300C00023 Clinical Study Report
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Investigators

Principal Investigator

Jeffrey Skolnik

AstraZeneca