Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Rigel Pharmaceuticals
Study ID
NCT00446095
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Patients: B-cell lymphoma, refractory, diffuse, nodular, mantle, other Phase I : Two groups of 6 patients, escalating dose tolerability- 28 days Phase II: Three groups of 16 patients (nodular, diffuse large cell, mantle cell plus others). Oral bid dosing with highest tolerable dose until toxicity, progression, or withdrawal

Key Dates

Start date
Apr 30, 2007
Status verified
Aug 2016
Primary completion
Apr 30, 2010
Completion
Oct 31, 2010

Study Design

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

Arms

  • Experimental: fostamatinib

Primary Outcome Measure

Overall Response Rate as Assessed According to the"Revised Response Criteria for Malignant Lymphoma" (Cheson 2007). [ 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 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) ]

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90095-
Research SiteStanfordCalifornia94305-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60612-
Research SiteIndianapolisIndiana46202-
Research SiteBostonMassachusetts02115-
Research SiteRochesterMinnesota59905-
Research SiteOmahaNebraska68198-
Research SiteNew YorkNew York10065-
Research SiteRochesterNew York14642-
Research SiteClevelandOhio44195-

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