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Phase I/II dose-escalation study of oral nilotinib (Tasigna) in imatinib-resistant or -intolerant Ph+ leukemias
2004-001483-51Phase 2Completed
- Sponsor
- Novartis
- Start
- Apr 2005
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 2, open-label, single-arm trial of nilotinib in chronic myelogenous leukemia (CML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL) and 2 more, sponsored by Novartis. Primary endpoints: Phase I: Maximum tolerated dose and recommended Phase II dose of nilotinib, Phase I: Safety and tolerability of nilotinib and 1 more. Started Apr 2005; status: completed.
02
Drugs
nilotinib
03
Conditions
chronic myelogenous leukemia (CML)chronic myeloid leukemia (CML)acute lymphoblastic leukemia (ALL)systemic mastocytosis (SM)hypereosinophilic syndrome (HES)
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