A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.
A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.
The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions:
Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1)
Group A - Imatinib failure only (arms 2, 3 and 4)
Group B - Imatinib and other TKI failure (arms 2, 3 and 4)
Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5)
Systemic mastocytosis (Sm) (arm 6)
Inclusion Criteria:
Main inclusion criteria include:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Tampa, Florida 33612, United States
Chicago, Illinois 60637, United States
Beech Grove, Indiana 46107, United States
Baltimore, Maryland 21231, United States
Nashville, Tennessee 37212, United States
HUS Helsinki, FIN-00029, Finland
Frankfurt/M, 60590, Germany
Pokfulam, Hong Kong, Hong Kong
Hwasun-gun, Jeollanam-do 519-809, South Korea
Niaosong Township, Taiwan 83301, Taiwan
Glasgow - Scotland, G12 OYN, United Kingdom