Clinical Trial: NCT02081378
A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2024-03-18 |
Study Overview
Brief Summary
The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic leukemia (Ph+ ALL) patients who are relapsed or refractory to or are intolerant of Tyrosine kinase inhibitors (TKIs), and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.
Official Title
Conditions
Intervention / Treatment
- Drug: Asciminib (ABL001)
- Drug: Nilotinib
- Drug: Imatinib
- Drug: Dasatinib
Other Study ID Numbers
- CABL001X2101
- 2013-004491-36
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2024-03-18 |
Study Overview
Brief Summary
The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic leukemia (Ph+ ALL) patients who are relapsed or refractory to or are intolerant of Tyrosine kinase inhibitors (TKIs), and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.
Official Title
Conditions
Intervention / Treatment
- Drug: Asciminib (ABL001)
- Drug: Nilotinib
- Drug: Imatinib
- Drug: Dasatinib
Other Study ID Numbers
- CABL001X2101
- 2013-004491-36