Phase 2
N=121
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00529763 ↗Enrolled (actual)
121
Serious AEs
45.5%
Results posted
Apr 2011
Primary outcome: Primary: Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR) — 50.8 Percentage of 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
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR) |
50.8 | — |
| PRIMARY Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) |
52.0; 16.2; 84.0; 29.7; 92.0; 35.1 | — |
| SECONDARY Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR) |
91.5 | — |
| SECONDARY Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants |
12.1 | — |
| SECONDARY Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants |
NA | — |
| SECONDARY Progression-free Survival Among CP CML Participants |
NA | — |
| SECONDARY Time to Complete and Major Hematologic Response (CHR and MaHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Participants (Ph+ ALL) |
16.0; 12.1; 12.1; 12.1; 12.1; 12.1 | — |
| SECONDARY Duration of CHR Among AD CML and Ph+ ALL Participants |
NA; NA | — |
| SECONDARY Duration of MaHR Among AD CML and Ph+ ALL Participants |
NA; 11.2 | — |
| SECONDARY Progression-free Survival Among AD CML and Ph+ ALL Participants |
25.7; 4.3 | — |
| SECONDARY Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Drug-related Fluid Retention AEs of Special Interest |
4; 4; 13; 18; 13; 24 | — |
| SECONDARY Mean Dasatinib Plasma Concentrations |
56.74; 133.18; 54.57; 130.86; 29.50; 100.69 | — |
| SECONDARY Mean Maximum Concentration (Cmax) of Dasatinib Following 70 mg BID and 100 QD Dose Administration |
71.01; 170.53; 71.54; 181.79 | — |
| SECONDARY Mean (Tmax) and (T-Half) of Dasatinib Following 70 mg BID and 100 QD Dose Administration |
1.17; 1.50; 1.62; 1.23; 4.35; 4.78 | — |
| SECONDARY Mean (AUC[0-T]), (AUC[INF]), and (AUC[TAU])of Dasatinib Following 70 mg BID and 100 QD Dose Administration |
161.30; 505.73; 214.60; 567.30; 174.26; 526.33 | — |
| SECONDARY Mean Oral Clearance (CLo) of Dasatinib Following 70 mg BID and 100 QD Dose Administration |
564.97; 221.84; 441.08; 211.09 | — |
| SECONDARY Mean Apparent Volume of Distribution (Vz/F) of Dasatinib Following 70 mg BID and 100 QD Dose Administration |
3785.78; 1454.71; 3446.74; 1719.14 | — |
Summary
The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib, or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP CML and Ph+ALL).
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Signed Written Informed Consent
- Men and women, ages 18 years of age or older
- Subjects with Chronic Phase (CP) or Advanced Disease (AD) chronic myeloid leukemia (CML)/Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)
- Subjects resistant/intolerant to imatinib
- Subjects presenting:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2
- Adequate hepatic function
- Adequate renal function
- Sodium, Potassium, Magnesium, Phosphorus, Calcium higher or equal than the lower limit of normal range
Exclusion Criteria
- Women of child bearing potential who are not using adequate birth control
- Women who are pregnant or breastfeeding
- Subjects eligible for stem cell transplantation
- Serious uncontrolled medical disorder or active infection
- Uncontrolled or significant cardiovascular disease
- Concurrent incurable malignancy other than CML
- Subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, Dasatinib in the past
- History of significant bleeding unrelated to CML
Data sourced from ClinicalTrials.gov (NCT00529763). 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.