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ON 01910.Na

Phase I Study of ON 01910.Na in Refractory Leukemia or Myelodysplastic Syndrome (MDS)

Ensayo de Traws Pharma, Inc. en Acute Myelocytic Leukemia · Acute Lymphocytic Leukemia · Chronic Myelocytic Leukemia · Chronic Lymphocytic Leukemia · Myelodysplastic Syndromes (del registro, en inglés).

Más ensayos de: Leucemia linfocítica crónica · Síndromes mielodisplásicos.

Fase

Fase 1

Estado

Completado

Participantes

22

previstos

Centros

1

Fin del objetivo primario

nov 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2008.

Qué mide

Safety data, including laboratory parameters and adverse events, will be collected for all patients in order to determine the qualitative and quantitative toxicity, and reversibility of toxicity, of ON 01910.Na. (2 - 4 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, Phase I study to determine the highest amount of the study drug, ON 01910.Na, that can be safety given to patients with high risk myelodysplastic syndromes (MDS) or refractory leukemias. Patients will receive ON 01910.Na (at a starting dose of 650 mg/m2) intravenously by 3-day continuous infusion once every 2 weeks. Successive courses will use longer infusion times and/or higher doses of the drug until toxicity, effectiveness, or ineffectiveness is recognized. In addition, the amount of drug in the blood will be measured, any antitumor activity will be documented, and the biological effect of ON 01910.Na on cell-cycle pathways will be evaluated in peripheral blood mononuclear cells.

Más ensayos de TRAW

Todos los de TRAW, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00854646), actualizada en ene 2018.