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NCT01498445 · ClinicalTrials.gov registry record · Phase 1
An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01498445: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01498445 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01498445, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if combining Sprycel (dasatinib) and Dacogen (decitabine) can help to control Chronic Myeloid Leukemia (CML). The dose level of decitabine will also be studied. Dasatinib is designed to block the protein that is responsible for chronic myeloid leukemia. Decitabine is designed to affect the mechanism that cells use to control the expression of certain genes, some of which are important in the progression of CML. This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of patients with certain types of CML. Decitabine is FDA approved for the treatment of patients with myelodysplastic syndrome. The combination of these drugs to treat CML is investigational. Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.
Primary Outcome
Maximum tolerated dose (MTD) defined as highest dose at which 0 of 3 or \</= 1/6 participant experience a first cycle dose limiting toxicity (DLT).
Interventions
- DRUG Decitabine
- DRUG Dasatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-06-12 |
| Est. Completion | 2019-09-24 |
| Phase | Phase 1 |
Why NCT01498445 stopped before completion
NCT01498445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT01498445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01498445 about?
NCT01498445 is a clinical study titled "An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)". The goal of this clinical research study is to learn if combining Sprycel (dasatinib) and Dacogen (decitabine) can help to control Chronic Myeloid Leukemia (CML). The dose level of decitabine will also be studied. Dasatinib is designed to block the protein that is responsible for chronic myeloid le...
What is the current status of trial NCT01498445?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-06-12. Estimated completion is 2019-09-24.
What interventions are being tested in trial NCT01498445?
The interventions under investigation include: Decitabine (DRUG), Dasatinib (DRUG).
Who is sponsoring clinical trial NCT01498445?
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 NCT01498445's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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