Phase 2
N=23
A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Myeloid Leukemia, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00482703 ↗Enrolled (actual)
23
Serious AEs
43.5%
Results posted
Nov 2010
Primary outcome: Primary: Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 — 45; 29; 75; 92 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dasatinib (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 |
45; 29; 75; 92; 86; 100 | — |
| SECONDARY Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment |
11; 12; 4; 6; 0; 0 | — |
| SECONDARY Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 |
91; 86; 100; 83; 86; 80 | — |
| SECONDARY Time to Major Cytogenetic Response (MCyR) |
5.5; 4.2 | — |
| SECONDARY Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics |
— | — |
| SECONDARY Duration of MCyR |
— | — |
| SECONDARY Time to CHR |
1.0; 0.6 | — |
| SECONDARY Duration of CHR |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
| SECONDARY Expression of BCR-ABL Gene Mutations of RNA (mRNA) |
11; 11; 0; 1; 8; 3 | — |
| SECONDARY Mutational Spectrum of BCR-ABL |
1; 3; 1; 0; 0; 0 | — |
| SECONDARY Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study |
55; 92; 36; 67 | — |
| SECONDARY Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study |
91; 83 | — |
Summary
The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID)
Eligibility Criteria
Inclusion Criteria
- Philadelphia chromosome positive or bcr-abl gene positive Chronic phase Chronic Myelogenous Leukemia (CML) subjects must have primary or acquired resistance to Imatinib mesylate or have intolerance of imatinib mesylate
- Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
- Men and women, ages 20 to 75
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
Exclusion Criteria
- Subjects who are eligible and willing to undergo transplantation at pre-study
- Women who are pregnant or breastfeeding
- Uncontrolled or significant cardiovascular disease
- History of significant bleeding disorder unrelated to CML
- Adequate hepatic function
- Adequate renal function
- Medication that increases bleeding risk
- Medication that changes heart rhythms
- Subjects who are compulsory detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Data sourced from ClinicalTrials.gov (NCT00482703). 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.