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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00101647
Registration number
NCT00101647
Ethics application status
Date submitted
12/01/2005
Date registered
13/01/2005
Date last updated
15/04/2011
Titles & IDs
Public title
Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
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Scientific title
A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
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Secondary ID [1]
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0
CA180-005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Myelogenous Leukemia
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0
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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0
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Leukaemia - Chronic leukaemia
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Cancer
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0
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0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib
Experimental: 1 -
Treatment: Drugs: Dasatinib
Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major and Overall Hematologic Response (MaHR and OHR)
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Assessment method [1]
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MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed =4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4.
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Timepoint [1]
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Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
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Secondary outcome [1]
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Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)
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Assessment method [1]
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MaHR=best response of CHR or NEL. CHR=white blood cells =institutional upper limit of normal (iULN); absolute neutrophil count (ANC) =1000/mm3; platelets =100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts =5%; <5% myelocytes+metamyelocytes in PB; PB basophils = iULN; no extramedullary involvement. NEL=WBC =iULN; no blasts/promyelocytes in PB; bone marrow blasts =5%; <5% myelocytes+metamyelocytes in PB; PB basophils =iULN; no extramedullary involvement; at least 1 of: ANC =500/mm3 & <1000/mm3; platelets =20,000/mm3 & <100,000/mm3.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response)
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Assessment method [2]
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Percentage of participants in the Imatinib-Resistant Group who achieved MaHR and did not progress at Month 24, based on the Kaplan-Meier estimate of the duration of response. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR and NEL are specified in Outcome Measure 2.
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months
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Assessment method [3]
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Percentage of participants who achieved OHR and did not progress at specified timepoints, based on the Kaplan-Meier estimate of the duration of response. OHR=best confirmed response of MaHR or MiHR. MaHR criteria in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response= confirmed =4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.
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Timepoint [3]
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12 months, 24 months
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Secondary outcome [4]
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Median Time in Days From First Dosing Date to Date of MaHR
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Assessment method [4]
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MaHR=best response of CHR or NEL. CHR=white blood cells =institutional upper limit of normal (iULN); absolute neutrophil count (ANC) =1000/mm3; platelets =100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts =5%; <5% myelocytes+metamyelocytes in PB; PB basophils = iULN; no extramedullary involvement. NEL=WBC =iULN; no blasts/promyelocytes in PB; bone marrow blasts =5%; <5% myelocytes+metamyelocytes in PB; PB basophils =iULN; no extramedullary involvement; at least 1 of: ANC =500/mm3 & <1000/mm3; platelets =20,000/mm3 & <100,000/mm3.
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Timepoint [4]
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Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
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Secondary outcome [5]
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Time to OHR
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Assessment method [5]
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Median time (in months) from first dosing date to date of OHR. OHR=best confirmed response of MaHR or MiHR. Criteria for MaHR specified in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response = response confirmed =4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.
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Timepoint [5]
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Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
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Secondary outcome [6]
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Best Cytogenetic Response
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Assessment method [6]
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Number of participants with complete, partial, minor, minimal, or no cytogenetic response. Determination of cytogenetic response based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).
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Timepoint [6]
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Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment
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Secondary outcome [7]
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Best Confirmed Hematologic Response
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Assessment method [7]
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Number of participants with confirmed complete hematologic response (CHR) or No Evidence of Leukemia (NEL), minor hematologic response (MiHR), or no hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for CHR and NEL are specified in Outcome Measure 2; criteria for MiHR are specified in Outcome Measure 4.
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Timepoint [7]
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Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
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Secondary outcome [8]
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Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period
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Assessment method [8]
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Number of participants who achieved an MMR at any time during the treatment period. MMR was calculated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).
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Timepoint [8]
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Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).
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Secondary outcome [9]
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MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations
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Assessment method [9]
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Major hematologic and cytogenetic responses (MaHR and MCyR) to dasatinib in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). BCR-ABL=the fused gene found in subjects with this type of CML. Criteria for MaHR are specified in Outcome Measure 2. MCyR=combined complete cytogenetic and partial cytogenetic response rate. Complete Cytogenetic Response= 0% Ph+ Cells in Metaphase in Bone Marrow, Partial Cytogenetic Response > 0% to 35% Ph+ Cells in Metaphase in Bone Marrow.
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Timepoint [9]
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Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).
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Secondary outcome [10]
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Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)
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Assessment method [10]
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Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, and functional well-being (PWB, SWB, EWB, FWB). Total score=0 to 108; higher score=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, and FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinically important change.
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Timepoint [10]
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Baseline, every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up.(treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).
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Secondary outcome [11]
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Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation
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Assessment method [11]
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AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
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Timepoint [11]
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Continuous from pretreatment through each 4-week cycle and at follow-up. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).
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Secondary outcome [12]
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Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)
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Assessment method [12]
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The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.
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Timepoint [12]
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Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
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Secondary outcome [13]
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Pharmacokinetics (PK) of Dasatinib and Its 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 Hours (AUC[0-T])
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Assessment method [13]
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The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.
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Timepoint [13]
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Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
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Secondary outcome [14]
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Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)
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Assessment method [14]
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The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.
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Timepoint [14]
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Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
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Secondary outcome [15]
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Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)
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Assessment method [15]
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The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.
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Timepoint [15]
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Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
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Secondary outcome [16]
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Population PK of Dasatinib
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Assessment method [16]
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Population pharmacokinetic analysis was not done because it is not meaningful for this single study
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Timepoint [16]
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Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.
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Eligibility
Key inclusion criteria
- Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL
positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease has
primary or acquired hematologic resistance to imatinib mesylate or who are intolerant
of imatinib mesylate.
- Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not
need to be their most recent CML treatment prior to coming on this study.
- Men and women, 18 years of age or older.
- Adequate hepatic function.
- Adequate renal function.
- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for a period of least 1
month before and at least 3 months after the study in such a manner that the risk of
pregnancy is minimized.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Women who are pregnant or breastfeeding.
- Subjects who are eligible and willing to undergo transplantation during the screening
period.
- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subjects to receive protocol therapy.
- Uncontrolled or significant cardiovascular disease.
- Medications that increase bleeding risk.
- Medications that change heart rhythms.
- Dementia or altered mental status that would prohibit the understanding or rendering
of informed consent.
- History of significant bleeding disorder unrelated to CML.
- Concurrent incurable malignancy other than CML.
- Evidence of organ dysfunction or digestive dysfunction that would prevent
administration of study therapy.
- Prior therapy with dasatinib (BMS-354825).
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
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Accrual to date
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Final
197
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Local Institution - St. Leonards
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Recruitment hospital [2]
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Local Institution - South Brisbane
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Recruitment hospital [3]
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Local Institution - East Melbourne
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Recruitment hospital [4]
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Local Institution - Parkville
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Recruitment hospital [5]
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Local Institution - Wien
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Recruitment postcode(s) [1]
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- St. Leonards
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Recruitment postcode(s) [2]
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- South Brisbane
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Recruitment postcode(s) [3]
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- East Melbourne
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Recruitment postcode(s) [4]
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- Parkville
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Recruitment postcode(s) [5]
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- Wien
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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Country [2]
0
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United States of America
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State/province [2]
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California
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Country [3]
0
0
United States of America
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State/province [3]
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Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Illinois
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kansas
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Country [7]
0
0
United States of America
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State/province [7]
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Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
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Massachusetts
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Country [9]
0
0
United States of America
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State/province [9]
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0
Michigan
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Country [10]
0
0
United States of America
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State/province [10]
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0
Missouri
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Country [11]
0
0
United States of America
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State/province [11]
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0
New Jersey
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New York
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Oregon
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Pennsylvania
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Country [15]
0
0
United States of America
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State/province [15]
0
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Tennessee
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Texas
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Country [17]
0
0
Argentina
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State/province [17]
0
0
Buenos Aires
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Country [18]
0
0
Argentina
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State/province [18]
0
0
Cordoba
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Country [19]
0
0
Belgium
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State/province [19]
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B-Leuven
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Country [20]
0
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Belgium
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State/province [20]
0
0
Edegem
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Country [21]
0
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Brazil
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State/province [21]
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Campinas
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Country [22]
0
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Brazil
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State/province [22]
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Rio De Janeiro
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Country [23]
0
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Brazil
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State/province [23]
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Sao Paulo
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Country [24]
0
0
Canada
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State/province [24]
0
0
Ontario
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Country [25]
0
0
Denmark
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State/province [25]
0
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Aarhus
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Country [26]
0
0
Finland
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State/province [26]
0
0
Helsinki
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Country [27]
0
0
France
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State/province [27]
0
0
LIlle
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Country [28]
0
0
France
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State/province [28]
0
0
Lyon Cedex 03
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Country [29]
0
0
France
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State/province [29]
0
0
Nantes
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Country [30]
0
0
France
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State/province [30]
0
0
Paris
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Country [31]
0
0
France
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State/province [31]
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Pessac
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Country [32]
0
0
France
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State/province [32]
0
0
Poitiers Cedex
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Country [33]
0
0
France
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State/province [33]
0
0
Strasbourg Cedex
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Country [34]
0
0
Germany
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State/province [34]
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0
Hamburg
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Country [35]
0
0
Germany
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State/province [35]
0
0
Mainz
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Country [36]
0
0
Germany
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State/province [36]
0
0
Mannheim
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Country [37]
0
0
Israel
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State/province [37]
0
0
Ramat-Gan
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Country [38]
0
0
Italy
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State/province [38]
0
0
Bologna
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Country [39]
0
0
Italy
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State/province [39]
0
0
Napoli
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Country [40]
0
0
Italy
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State/province [40]
0
0
Orbassano
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Country [41]
0
0
Italy
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State/province [41]
0
0
Roma
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Country [42]
0
0
Korea, Republic of
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State/province [42]
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0
Jeollanam-Do
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Country [43]
0
0
Korea, Republic of
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State/province [43]
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Kyunggi-Do
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Country [44]
0
0
Korea, Republic of
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State/province [44]
0
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Seoul
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Country [45]
0
0
Netherlands
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State/province [45]
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0
Nijmegen
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Country [46]
0
0
Netherlands
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State/province [46]
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0
Rotterdam
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Country [47]
0
0
Norway
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State/province [47]
0
0
Trondheim
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Country [48]
0
0
Peru
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State/province [48]
0
0
Lima
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Country [49]
0
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Philippines
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State/province [49]
0
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Quezon City
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Country [50]
0
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Singapore
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State/province [50]
0
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Singapore
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Country [51]
0
0
Sweden
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State/province [51]
0
0
Gothenburg
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Country [52]
0
0
Sweden
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State/province [52]
0
0
Lund
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Country [53]
0
0
Sweden
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State/province [53]
0
0
Umea
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Country [54]
0
0
Sweden
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State/province [54]
0
0
Uppsala
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Country [55]
0
0
Switzerland
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State/province [55]
0
0
Basel
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Country [56]
0
0
Taiwan
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State/province [56]
0
0
Taipei
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Country [57]
0
0
Taiwan
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State/province [57]
0
0
Taoyuan
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Country [58]
0
0
Thailand
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State/province [58]
0
0
Bangkok
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Country [59]
0
0
United Kingdom
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State/province [59]
0
0
Central
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Country [60]
0
0
United Kingdom
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State/province [60]
0
0
Greater London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this clinical research study is to learn if BMS-354825 will have activity,
defined by hematologic response, in subjects who have accelerated phase chronic myeloid
leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this
treatment will also be studied.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00101647
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Trial related presentations / publications
Guilhot F, Apperley J, Kim DW, Bullorsky EO, Baccarani M, Roboz GJ, Amadori S, de Souza CA, Lipton JH, Hochhaus A, Heim D, Larson RA, Branford S, Muller MC, Agarwal P, Gollerkeri A, Talpaz M. Dasatinib induces significant hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase. Blood. 2007 May 15;109(10):4143-50. doi: 10.1182/blood-2006-09-046839. Epub 2007 Jan 30.
Apperley JF, Cortes JE, Kim DW, Roy L, Roboz GJ, Rosti G, Bullorsky EO, Abruzzese E, Hochhaus A, Heim D, de Souza CA, Larson RA, Lipton JH, Khoury HJ, Kim HJ, Sillaber C, Hughes TP, Erben P, Van Tornout J, Stone RM. Dasatinib in the treatment of chronic myeloid leukemia in accelerated phase after imatinib failure: the START a trial. J Clin Oncol. 2009 Jul 20;27(21):3472-9. doi: 10.1200/JCO.2007.14.3339. Epub 2009 Jun 1.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00101647
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