Phase 2
N=109
Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
Chronic Myeloid Leukemia · Blast Crisis
Bottom Line
View on ClinicalTrials.gov: NCT00101816 ↗Enrolled (actual)
109
Serious AEs
79.8%
Results posted
Mar 2010
Primary outcome: Primary: Major and Overall Hematologic Response (MaHR and OHR) — 2; 34; 36; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dasatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major and Overall Hematologic Response (MaHR and OHR) |
2; 34; 36; 4; 50; 54 | — |
| SECONDARY Median Duration of Major Hematologic Response (MaHR) |
22.4 | — |
| SECONDARY Median Duration of Overall Hematologic Response (OHR) |
14.7 | — |
| SECONDARY Time to MaHR and OHR |
63.5; 30.0 | — |
| SECONDARY Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response |
2; 27; 29; 0; 8; 8 | — |
| SECONDARY Number of Participants With CHR or NEL, MiHR, or no Hematologic Response |
2; 26; 28; 0; 8; 8 | — |
| SECONDARY Number of Participants Achieving Major Molecular Response (MMR) |
2; 11; 13; 0; 1; 1 | — |
| SECONDARY MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations |
31; 29; 26; 26; 38; 13 | — |
| SECONDARY Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) |
5; 46; 51; 5; 54; 59 | — |
| SECONDARY Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs |
6; 38; 44; 6; 49; 55 | — |
| SECONDARY Pharmacokinetics (PK) of Dasatinib - Maximum Observed Plasma Concentration (Cmax) |
60.34; 110.42 | — |
| SECONDARY Pharmacokinetics (PK) of Dasatinib - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(AUC[0-T]) |
161.17; 295.92 | — |
| SECONDARY Pharmacokinetics (PK) of Dasatinib - Time to Maximum Observed Plasma Concentration (Tmax) |
1.79; 1.22 | — |
| SECONDARY Pharmacokinetics (PK) of Dasatinib - Plasma Half-life (T-HALF) |
3.71; 4.26 | — |
| SECONDARY Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax) |
2.44; 3.87 | — |
| SECONDARY Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h (AUC[0-T]) |
7.08; 13.81 | — |
| SECONDARY Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax) |
1.71; 1.90 | — |
| SECONDARY Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF) |
4.95; 4.38 | — |
| SECONDARY Population PK of Dasatinib |
— | — |
Summary
The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects with myeloid blast phase chronic myeloid leukemia
- Subjects who are either resistant or intolerant of imatinib mesylate
Exclusion Criteria
- Subjects who are eligible and willing to undergo transplantation
- Serious uncontrolled medical disorder or active infection
- Uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc
- Subjects receiving medications that may affect heart rhythm
- Other malignancy/cancer other than CML
- History of significant bleeding disorder unrelated to CML
- Pregnant or breastfeeding women (subjects must avoid becoming pregnant)
- Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days
- Subject is receiving medications that affect platelet function or an anticoagulant
Data sourced from ClinicalTrials.gov (NCT00101816). 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.