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Clofarabine

A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)

Ensayo de Sanofi en Myelodysplastic Syndromes · Secondary Acute Myeloid Leukemia (AML) (del registro, en inglés).

Más ensayos de: Síndromes mielodisplásicos.

Fase

Fase 2

Estado

Completado

Participantes

38

previstos

Centros

6

Fin del objetivo primario

may 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2007.

Qué mide

Percentage of Participants With Overall Response (From date of randomization until disease recurrence or death, whichever occurred first (maximum study duration: up to 4 years)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThere was no well accepted standard of care for participants who failed or were intolerant to any of the currently approved therapies for myelodysplastic syndromes (MDS). In this study, participants were initially assigned to receive 55 or 35 milligrams (mg) of oral clofarabine daily for 5 days. After safety review of the first participants enrolled, the dose was reduced to 25 milligrams per day (mg/day) for up to 8 cycles as long as the participants continued to benefit and in the absence of progressive disease.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00531232), actualizada en mar 2022.