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NCT02225574 · ClinicalTrials.gov registry record · Phase 1
An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination for Patients With Refractory or Advanced Chronic Myeloid Leukemia and Philadelphia Positive Acute Leukemia (Protocol CAMN107AUS41T)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02225574: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02225574 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02225574, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerated dose of the combination of nilotinib and MEK-162 that can be given to patients with CML or acute leukemia. Researchers also want to learn if the drug combination can help to control the disease. The safety of the drug combination will also be studied.
Primary Outcome
MTD defined as maximum daily oral dose at which \<33% of patients experience a dose limiting toxicity (DLT) during first 28 days. DLT defined by events that are clinically significant and at least possibly related to study drug occurring during the first 4 weeks of therapy. Toxicities reported on a scale of 1-4 according to the NCI criteria Common Terminology Criteria for Adverse Events (CTCAE).
Interventions
- BEHAVIORAL Questionnaires
- DRUG Nilotinib
- DRUG MEK-162
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-03-11 |
| Est. Completion | 2017-02-02 |
| Phase | Phase 1 |
Why NCT02225574 stopped before completion
NCT02225574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Questionnaires is the first listed.
NCT02225574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02225574 about?
NCT02225574 is a clinical study titled "An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination for Patients With Refractory or Advanced Chronic Myeloid Leukemia and Philadelphia Positive Acute Leukemia (Protocol CAMN107AUS41T)". The goal of this clinical research study is to find the highest tolerated dose of the combination of nilotinib and MEK-162 that can be given to patients with CML or acute leukemia. Researchers also want to learn if the drug combination can help to control the disease. The safety of the drug combinat...
What is the current status of trial NCT02225574?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2015-03-11. Estimated completion is 2017-02-02.
What interventions are being tested in trial NCT02225574?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Nilotinib (DRUG), MEK-162 (DRUG).
Who is sponsoring clinical trial NCT02225574?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02225574's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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