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NCT01218477 · ClinicalTrials.gov registry record · Phase 1
Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML)
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01218477: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01218477 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01218477, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the safety and tolerability of the combination of BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.
Primary Outcome
The following drug-related adverse events (AEs) occurring in the first 28 days of treatment were considered dose-limiting toxicities (DLT): Grade 4 hematologic AE lasting \>7 days; ≥Grade 3 nonhematologic AE, despite medical intervention; ≥Grade 2 AE uncontrolled by medical intervention and requiring treatment interruption for \>7 days. RP2D was that dose at which ≤1 of 6 patients had a DLT in the first 4 weeks of treatment. If \<3 patients were DLT-evaluable, up to 6 additional patients entered
Interventions
- DRUG Dasatinib
- DRUG BMS-833923
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01218477 record still lists
NCT01218477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Dasatinib is the first listed.
NCT01218477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01218477 about?
NCT01218477 is a clinical study titled "Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML)". The purpose of the study is to determine the safety and tolerability of the combination of BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.
What is the current status of trial NCT01218477?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2011-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01218477?
The interventions under investigation include: Dasatinib (DRUG), BMS-833923 (DRUG).
Who is sponsoring clinical trial NCT01218477?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01218477's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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