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A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleA Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Current status of trialCompleted
Sponsors and collaboratorsBristol-Myers Squibb
Information provided byBristol-Myers Squibb
ClinicalTrials.gov identifierNCT00482703
PurposeThe 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)
Condition(s)Myeloid Leukemia, Chronic
Intervention(s)Drug: Dasatinib
Drug: dasatinib
PhasePhase I/Phase II
Study type and designAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleA Randomized, Multicenter, Open-label Phase II Study of Dasatinib (BMS-354825) Administered Orally at a Dose of 50mg Twice Daily or 100mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Imatinib
Primary outcomeCytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 Week 24 No Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).
Secondary outcomeAdverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day. Yes AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 Week 24 No CHR=all of the following criteria: white blood cell count ⿤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.
Time to Major Cytogenetic Response (MCyR) time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met No Time to MCyR is defined as the time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met. MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35
Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration. No Blood sample collection for pharmacokinetic (PK) analysis that will contribute to PK modeling.
Duration of MCyR from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death No The duration of MCyR will be measured from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death. Subjects who neither progress nor die will be censored on the date of their last cytogenetic assessment.MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Philadelphia-positive (Ph+) Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35
Time to CHR time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met No Time to CHR = time from first dose of Dasatinib until the first day CHR criteria are met (provided subjects achieved a cCHR). CHR=all of the following criteria: white blood cell count ⿤ upper limit of normal; platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.
Duration of CHR measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death No The duration of CHR were measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death. Subjects who neither progress nor die were censored on the date of their last hematologic assessment.
Progression-Free Survival (PFS) time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met No Progressed disease=achieving a CHR & subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose & increase in white blood cell count (doubling of count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done â¿¥2 weeks apart); meeting the criteria of accelerated or blastic phase chronic myeloid leukemia at any time; having an MCyR & subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.
Expression of BCR-ABL Gene Mutations of RNA (mRNA) Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) No Number of participants with positive (>= 2.0 log copies/mg) and negative (<2.0 log copies/mg) expression of mRNA at Baseline and at end of study.
Mutational Spectrum of BCR-ABL Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) No Number of participants with a particular BCR-ABL mutation at Baseline and End-of-Study.
Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) No Cytogenetic response (CyR) as reflected in the major cytogenetic response was determined by bone marrow (BM) aspirates and are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each BM sample. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), or Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).
Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) No CHR=all of the following criteria: white blood cell count ⿤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.
Study startMay 2007
Minimum age20 Years
Maximum age75 Years
GenderBoth
Eligibility criteriaInclusion 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
Study chairs or principal investigatorsBristol-Myers Squibb, Study Director, Bristol-Myers Squibb
LocationsAichi, Japan

Local Institution
Nagoya
Aichi
464-8681

Hyogo, Japan

Local Institution
Nishinomiya-Shi
Hyogo
663-8501

Kagoshima, Japan

Local Institution
Kagoshima-Shi
Kagoshima
890-0064

Kanagawa, Japan

Local Institution
Isehara-Shi
Kanagawa
259-1193

Shizuoka, Japan

Local Institution
Hamamatsu-Shi
Shizuoka
431-3192

Tokyo, Japan

Local Institution
Bunkyo-Ku
Tokyo
113-8677

Tokyo, Japan

Local Institution
Chuo-Ku
Tokyo
104-0045

Tokyo, Japan

Local Institution
Shibuya-Ku
Tokyo
150-8935

Japan

Local Institution
Kyoto
LinksBMS Clinical Trials Disclosure
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Study ID numbersCA180-138
Last updatedNovember 30, 2010
Record first receivedJune 4, 2007
ClinicalTrials.gov identifierNCT00482703
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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