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CML Clinical Trials in Tasigna®




Job: Trials Spectrum Card CML
Study Name Purpose Design Study ID/
[ClinicalTrials.gov ID]
ClinicalTrials.gov ID
A study of oral AMN107 (Nilotinib) in Adults with CML or Other Blood Related Cancers Assess efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 (Nilotinib) in six groups of patients with one of the following conditions: Imatinib Resistant/Intolerant:
CML-Chronic Phase (CP)
CML-Accelerated Phase (AP)
CML-Blast Crisis (BC)
Relapsed/refractory Ph+ALL Hypereosinophilic syndrome (HES)
Systemic Mastocytosis (SM)

 Treatment, Randomized, Open Label, Dose Comparison, Safety and Efficacy CAMN107A2101

[NCT00109707]
ENESTnd
Nilotinib vs imatinib i00n patients with newly diagnosed Ph+ CML-CP 		Compare the efficacy and safety of 2 doses of nilotinib (300 mg BID and 400 mg BID) versus imatinib (400 mg QD)
 Treatment,
Randomized,
Open Label,
Dose Comparison,
Crossover Assignment,
Safety and Efficacy 		CAMN107A2303

[NCT00471497]
ENACT
Multicenter, expanded access study of nilotinib in patients with Ph+ CML who are resistant to or intolerant to imatinib		 Evaluate the safety of nilotinib in adult patients with Ph+ CML in the CP, AP or blast crisis who are resistant to or intolerant to imatinib. Treatment,
Nonrandomized,
Open Label,
Uncontrolled,
Single Group Assignment,
Safety		 CAMN107A2109

[NCT00302016]


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