Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Rigel Pharmaceuticals
Study ID
NCT00798096
Phase
PHASE2
Status
Completed

Conditions

  • T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor measurements using CT and PET (when indicated) scans and physical exam at baseline, and 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.

Key Dates

Start date
Mar 31, 2009
Status verified
Aug 2016
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD). [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteSan FranciscoCalifornia94143-
Research SiteStanfordCalifornia94305-
Research SiteAtlantaGeorgia30322-
Research SiteBostonMassachusetts02115-
Research SiteRochesterMinnesota55905-
Research SiteOmahaNebraska68198-
Research SiteNew YorkNew York10021-
Research SiteHoustonTexas77030-

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