Overview

This trial is active, not recruiting.

Condition leukemia
Treatment dasatinib
Phase phase 2
Target BCR-ABL
Sponsor Bristol-Myers Squibb
Start date November 2007
End date June 2009
Trial size 121 participants
Trial identifier NCT00529763, CA180-160

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
dasatinib Sprycel
Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study

Primary Outcomes

Measure
Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR)
time frame: 12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)
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 Subjects (Ph+ ALL)
time frame: 12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)

Secondary Outcomes

Measure
Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR)
time frame: 12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)
Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants
time frame: 12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)
Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants
time frame: Duration of MCyR was measured for CP CML subjects with MCyR from the first day all criteria were met for CCyR or PCyR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)
Progression-free Survival Among CP CML Participants
time frame: 12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)
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)
time frame: 12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)
Duration of CHR Among AD CML and Ph+ ALL Participants
time frame: Duration of CHR was measured for AD CML and Ph+ ALL subjects with CHR from the first day all criteria were met for CHR until the date of disease progression (PD) or death.(data cut-off date: 18-Jun-2010)
Duration of MaHR Among AD CML and Ph+ ALL Participants
time frame: Duration of MaHR was measured for AD CML and Ph+ ALL subjects with MaHR from the first day all criteria were met for MaHR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)
Progression-free Survival Among AD CML and Ph+ ALL Participants
time frame: 12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)
Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Grade 3/4 Hematologic Abnormalities
time frame: 18 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)
Mean Dasatinib Plasma Concentrations
time frame: Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Days 6 and 7 (0 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose),
Mean Maximum Concentration (Cmax) of Dasatinib Following 70 mg BID and 100 QD Dose Administration
time frame: Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)
Mean (Tmax) and (T-Half) of Dasatinib Following 70 mg BID and 100 QD Dose Administration
time frame: Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)
Mean (AUC[0-T]), (AUC[INF]), and (AUC[TAU])of Dasatinib Following 70 mg BID and 100 QD Dose Administration
time frame: Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)
Mean Oral Clearance (CLo) of Dasatinib Following 70 mg BID and 100 QD Dose Administration
time frame: Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)
Mean Apparent Volume of Distribution (Vz/F) of Dasatinib Following 70 mg BID and 100 QD Dose Administration
time frame: Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)

Eligibility Criteria

Male or female participants at least 18 years old.

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: 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2 2. Adequate hepatic function 3. Adequate renal function 4. 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

Additional Information

Official title A Phase II Study to Determine the Activity of Dasatinib Administered Orally (PO) at a Dose of 100 mg Once Daily (QD) in Chronic Phase Chronic Myelogenous Leukemia (CML), at a Dose of 70 mg Twice Daily (BID) in Advanced Phase Chronic Myelogenous Leukemia (CML) Chinese Subjects Who Are Resistant to or Intolerant of Imatinib Mesylate (Gleevec®)
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.