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ON 01910.Na

Study of 72-Hour Infusion of ON 01910.Na in Patients With MDS or AML

Ensayo de Traws Pharma, Inc. en Sindromes mielodisplasicos · Leucemia mieloide aguda.

Más ensayos de: Síndromes mielodisplásicos · Leucemia mieloide aguda.

Fase

Fase 1/2

Estado

Completado

Participantes

36

previstos

Centros

1

Fin del objetivo primario

sep 2013

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Response as defined per the 2000 International Working Group (IWG) Criteria in patients with MDS. (6 -12 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na Concentrate when it is administered as an intravenous continuous infusion (IVCI) over 72 hours once every 2 weeks in a broad population of MDS patients. Rationale for this study is based on the activity observed in another study with ON 01910.Na in patients with refractory anemia with excess blasts (RAEB) 1 and 2 MDS. This study will examine ON 01910.Na in a broader population of MDS and AML patients. This phase I/II study will establish the Maximum Tolerated Dose (MTD) starting with a dose of 800 mg/m2 per day administered over 24 hours for 2 consecutive days as a continuous intravenous infusion, once a week for 3 weeks of a 4-week cycle and examine the efficacy and safety profile at the MTD.

Más ensayos de TRAW

Todos los de TRAW, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00854945), actualizada en jun 2017.