Phase 2
N=150
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
Chronic Myeloid Leukemia · Philadelphia-Positive Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00103844 ↗Enrolled (actual)
150
Serious AEs
31.3%
Results posted
Jan 2010
Primary outcome: Primary: Number of Participants With Major Cytogenetic Response (MCyR) at Week 12 — 36; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dasatinib (Drug); Imatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Cytogenetic Response (MCyR) at Week 12 |
36; 14 | — |
| SECONDARY MCyR at Any Time Prior to Crossover |
54; 16; 44; 9; 10; 7 | — |
| SECONDARY Duration of MCyR at 12 Months and 18 Months |
92; 74; 90; 74 | — |
| SECONDARY Duration of MCyR at 24 Months |
90 | — |
| SECONDARY Time to MCyR Prior to Crossover |
2.8; 2.8 | — |
| SECONDARY Complete Hematologic Response (CHR) at Any Time Prior to Crossover |
94; 40 | — |
| SECONDARY Duration of Complete Hematologic Response (CHR) |
92; 82; 84; 73 | — |
| SECONDARY Time to CHR Prior to Crossover |
2.1; 2.1 | — |
| SECONDARY Major Molecular Response (MMR) |
29; 6 | — |
| SECONDARY CHR After Crossover |
37; 13 | — |
| SECONDARY Cytogenetic Response After Crossover |
19; 3; 15; 0; 4; 3 | — |
| SECONDARY Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover |
100; 45; 67; 21; 94; 44 | — |
| SECONDARY Health-Related Quality of Life Prior to Crossover |
— | — |
| SECONDARY Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib |
78 | — |
Summary
The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.
Eligibility Criteria
Inclusion Criteria
- Men and women, 18 years of age or older.
- Subjects with Chronic Phase Ph+ CML.
- Subjects have not been treated with imatinib at a dose >600 mg/day.
- Subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day.
- Able to tolerate imatinib at the highest dose the subject had received in the past.
- Demonstrate adequate renal and hepatic function.
- Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.
Exclusion Criteria
- Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study.
- Women using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above.
- Prior treatment with imatinib at a dose >600 mg/day.
- Subjects who have previously identified specific BCR-ABL mutations.
- Previous diagnosis of accelerated phase or blast crisis CML.
- Intolerance to imatinib at any dose.
- Subjects who are eligible and willing to undergo transplantation during the screening period.
- Serious uncontrolled medical disorder or active infection.
- Uncontrolled or significant cardiovascular disease.
- Uncontrolled hypertension.
- Dementia or altered mental status.
- Evidence of organ dysfunction.
- Use of imatinib within 7 days.
- Use of interferon or cytarabine within 14 days.
- Use of a targeted small molecule anticancer agent within 14 days.
- Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
- Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
- Prior therapy with BMS-354825.
Data sourced from ClinicalTrials.gov (NCT00103844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.