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NCT02081378 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 326
- Enrollment target
NCT02081378: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02081378 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 326 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (443% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02081378, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 326 participants
- Enrollment target
Study 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.
Primary Outcome
Determine the MTD and/or RDE of ABL001 as single agent in CML and Ph+ ALL, and in combination with either nilotinib or imatinib or dasatinib in CML patients
Interventions
- DRUG Dasatinib
- DRUG Nilotinib
- DRUG Imatinib
- DRUG Asciminib (ABL001)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2014-04-24 |
| Est. Completion | 2023-03-14 |
| Phase | Phase 1 |
What the finished NCT02081378 record still lists
NCT02081378 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (443% higher).
The record links to 0 conditions, and to 4 interventions - of which Dasatinib is the first listed.
NCT02081378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02081378 about?
NCT02081378 is a clinical study titled "A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL". 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 in...
What is the current status of trial NCT02081378?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 326 participants. The study started on 2014-04-24. Estimated completion is 2023-03-14.
What interventions are being tested in trial NCT02081378?
The interventions under investigation include: Dasatinib (DRUG), Nilotinib (DRUG), Imatinib (DRUG), Asciminib (ABL001) (DRUG).
Who is sponsoring clinical trial NCT02081378?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02081378's enrollment target sits among peer trials
326 111th of 2000 higher than 1,890 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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