Clinical trial · Interventional
Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
NCT00324077CI-TRIAL-00020942withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient Enrollment
Summary
Brief summary (as posted)
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloid Leukemia, Chronic, Chronic-Phase | Myeloid Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib in combination with imatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
Secondary outcomes (7)
- measure
- assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
- measure
- identify dose limiting toxicities
- measure
- characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
- measure
- measure major molecular response rate
- measure
- measure the major cytogenetic response rate
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * males and females, 18 or older * chronic phase Ph+ or BCR-ABL positive CML * current complete hematologic response to imatinib * lack of major molecular response * on imatinib for at least one year * on the same imatinib dose for at least 6 months * adequate hepatic and renal function Exclusion Criteria: * History of accelerated or blast phase CML * Serious uncontrolled medical disorder or active infection * Significant cardiovascular disease or bleeding disorder * Concurrent use of medications at risk of causing Torsades de Pointe
References
Publications (0)
Data not yet available
No reference posted for this study.