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A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec-resistant CML in accelerated phase or blast crisis, relapsed/refrac...

Mise à jour : Il y a 5 ans
Référence : EUCTR2004-001483-51

A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec-resistant CML in accelerated phase or blast crisis, relapsed/refractory Ph+ ALL, systemic mastocytosis, or hypereosinophilic syndrome

Femme et Homme

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Extrait

•Determine the MTD and DLT of AMN107 as a single agent when administered as an oral once-daily dose to adult patients with Gleevec-resistant CML in accelerated phase or blast crisis, or relapsed/refractory Ph+ ALL. •To characterize the PK profile in plasma and, where samples are available, in tumor cells and normal hematopoietic cells

Critère d'inclusion

  • CML in accelerated phase or blast crisis, relapsed/refractory Ph+ ALL, systemic mastocytosis, or hypereosinophilic syndrome

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