CLINICAL TRIALS PROFILE FOR ASCIMINIB HYDROCHLORIDE
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All Clinical Trials for Asciminib Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03106779 ↗ | 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. |
| NCT03578367 ↗ | 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) |
| NCT03605277 ↗ | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Asciminib Hydrochloride
Condition Name
| Condition Name for Asciminib Hydrochloride | |
| Intervention | Trials |
| Chronic Myelogenous Leukemia | 4 |
| Chronic Myelogenous Leukemia - Chronic Phase | 2 |
| Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia | 1 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for Asciminib Hydrochloride
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Clinical Trial Progress for Asciminib Hydrochloride
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Clinical Trial Sponsors for Asciminib Hydrochloride
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