| 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] |
