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Fostamatinib Disodium

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

Ensayo de RIGEL PHARMACEUTICALS INC en T Cell Lymphoma (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

18

previstos

Centros

10

Fin del objetivo primario

abr 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2009.

Qué mide

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). (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)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPatients 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.

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Todos los de RIGL, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00798096), actualizada en ago 2016.