Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
Active, not recruiting
Novartis Pharmaceuticals
Phase 3
2017-10-26
The purpose of this pivotal study is to compare the efficacy of ABL001 with that of bosutinib
in the treatment of patients with CML-CP having previously been treated with a minimum of two
prior ATP-binding site TKIs.
Patients intolerant to the most recent TKI therapy must have BCR-ABL1 ratio > 0.1% IS at
screening and patients failing their most recent TKI therapy must meet the definition of
treatment failure as per the 2013 ELN guidelines.
Patients with documented treatment failure while on bosutinib treatment will have the option
to switch to asciminib treatment within 96 weeks after the last patient has been randomized
on study.
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
Active, not recruiting
Novartis Pharmaceuticals
Phase 2
2018-11-22
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or
asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated
patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)
Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched Healthy Volunteers
Completed
Novartis Pharmaceuticals
Phase 1
2018-11-16
The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of
asciminib following a single oral dose in adult subjects with renal impairment compared to a
matched group of healthy subjects with normal renal function.
The results will determine whether or not a dose adjustment should be recommended when
treating patients with asciminib who have impaired renal function.
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