Phase II, Multicenter, Simon Two-Stage Study of Fostamatinib Disodium in Patients With Relapsed or Refractory T-Cell Lymphoma
18 Years
N/A
Both
T Cell Lymphoma
Trial Information
Phase II, Multicenter, Simon Two-Stage Study of Fostamatinib Disodium in Patients With Relapsed or Refractory T-Cell Lymphoma
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 disease progression. In the initial stage of the study, a total of 19
patients will be enrolled and treated with Fostamatinib Disodium. Should at least 4 patients
exhibit a response at Week 8 or later of the study, the second stage of 36 patients will
open to enrollment. Efficacy will be assessed by CT and PET scans (when indicated) and
physical exam at baseline, and CT scans and physical exam of all disease-involved areas
every 8 weeks until progression. Safety will be assessed by periodic physical exams,
clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30
days following last study drug treatment. Blood samples for PK assessment will be obtained
from all patients enrolled in Stage 1 at protocol-defined intervals. Patients with
accessible tumor tissue will be asked to undergo a biopsy for a fresh tissue sample for
assessment of Syk activity in tumor tissue. Archived tissue samples from the initial
diagnostic biopsy and the most recent biopsy for lymphoma will be obtained in the event a
fresh tumor biopsy cannot be obtained. Patients who have accessible tumor tissue will be
asked to consent to a second tumor biopsy at Week 8, to assess the impact of Fostamatinib
Disodium treatment on the activity of Syk and its downstream markers. All baseline fresh or
archived tumor tissue samples will undergo central pathology review to confirm the diagnosis
of TCL.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary efficacy endpoint for this study is the overall response rate (ORR) [proportion of patients with best response of complete response (CR) or partial response (PR)].
Outcome Time Frame:
8 weeks
Safety Issue:
Yes
Principal Investigator
Jeffrey Skolnik, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D4300C00024
NCT ID:
NCT00798096
Start Date:
March 2009
Completion Date:
April 2010
Related Keywords:
- T Cell Lymphoma
- T Cell Lymphoma
- Lymphoma
- Lymphoma
- Lymphoma, T-Cell
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Albany, Georgia |
| Research Site | Beverly, Massachusetts |
| Research Site | Alexandria, Minnesota |
| Research Site | Grand Island, Nebraska |
| Research Site | Albany, New York |
| Research Site | Abilene, Texas |
