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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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 326 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02081378
The ClinicalTrials.gov registry entry for NCT02081378 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Dasatinib is the first listed.
NCT02081378 reports 0 study locations.
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.
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