Status:
COMPLETED
Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma
Lead Sponsor:
Rigel Pharmaceuticals
Conditions:
T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 respon...
Detailed Description
Up to 61 patients (male and female) meeting the inclusion and exclusion criteria will be enrolled into this trial in two stages. All enrolled patients will be treated with R788 at 200 mg PO bid until ...
Eligibility Criteria
Inclusion
- Patients must give written informed consent to participate in this study by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
- Males and females, 18 years of age or older.
- Patients must have histologically proven T-cell lymphoma (TCL).
- Patients must have documented disease progression after receiving at least one prior therapeutic regimen and must be patients for whom no known curative therapy exists.
Exclusion
- Patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study.
- Has a B-cell lymphoma, primary CNS lymphoma, or known lymphomatous involvement of the CNS, or any other NK/T-cell leukemia/lymphoma.
- Has uncontrolled or poorly controlled hypertension.
- Has had recent (within 1 month prior to Day 1) serious surgery or uncontrolled infectious disease.
- Has any concurrent malignancy requiring treatment.
- Has a known positive test for Hepatitis B surface Ag, Hepatitis C, or HIV.
- Has laboratory abnormalities.
- Has difficulty swallowing or malabsorption.
- Has an ECOG performance status \> 2.
- Has not recovered from adverse effects related to last prior therapy for lymphoma.
- Has had an allotransplantation within 90 days prior to Day 1 of treatment.
- Has been treated with a CYP3A4 inducer/inhibitor within 3 days prior to Day 1 of treatment or is expected to require treatment with CYP3A4 inducer/inhibitor during the course of the study.
- Has received systemic steroids at a dose greater than the equivalent of 10 mg/day of prednisone within 7 days prior to Day 1 of treatment.
- Has received any other investigational therapy within 5 half-lives of the agent or 2 weeks of Day 1 of treatment, whichever is longer.
- Is a female of childbearing potential unless menopausal, surgically sterile, or willing to use an effective method of birth control, (oral contraceptive, mechanical barrier, long-acting hormonal agent), during the study and for 30 days thereafter.
- Is pregnant or lactating.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00798096
Start Date
March 1 2009
End Date
April 1 2010
Last Update
September 19 2016
Active Locations (10)
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1
Research Site
San Francisco, California, United States, 94143
2
Research Site
Stanford, California, United States, 94305
3
Research Site
Atlanta, Georgia, United States, 30322
4
Research Site
Boston, Massachusetts, United States, 02115