Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 17 of 17

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Major and Overall Hematologic Response (MaHR and OHR)	Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment	All treated subjects	participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)	12 months	Population comprised of responders only.	percentage of responders	NUMBER
SECONDARY	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)	24 months	Population comprised of responders only. NOTE: Projected duration of MaHR at 24 months in the Imatinib-Intolerant group was beyond the maximum observed time for this cohort, and therefore only the Imatinib-Resistant group is presented.	percentage of responders	NUMBER
SECONDARY	Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months	12 months, 24 months	Population is comprised of responders only	Percentage of responders	NUMBER
SECONDARY	Median Time in Days From First Dosing Date to Date of MaHR	Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment	Population is comprised of responders only	Days	MEDIAN
SECONDARY	Time to OHR	Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment	Population comprised of responders only	days	MEDIAN
SECONDARY	Best Cytogenetic Response	Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment	All treated subjects	Participants	NUMBER
SECONDARY	Best Confirmed Hematologic Response	Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment	All treated subjects	Participants	NUMBER
SECONDARY	Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period	Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).	Number of Participants Analyzed=all treated subjects who were assessed for major molecular response; n=participants with or without CCyR in cohort.	participants	NUMBER
SECONDARY	MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations	Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).	All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 162 of the 174 subjects (12/13 imatinib-intolerant and 150/161 imatinib-resistant). At baseline, 89 (59%) imatinib-resistant subjects and 1 imatinib-intolerant subject expressed imatinib resistant mutations.	Percentage of participants	NUMBER
SECONDARY	Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)	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).	Number of participants with FACT-G assessments at baseline and at least one assessment during treatment	Participants	NUMBER
SECONDARY	Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation	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).		Participants	NUMBER
SECONDARY	Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)	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.	29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values \< than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.	ng/mL	MEAN
SECONDARY	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])	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.	29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values \< than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.	ng∙h/mL	MEAN
SECONDARY	Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)	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.	A total of 29 participants had dense PK sampling on both Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable concentration-time profiles. n=the number of participants on Day 1 and Day 8 who were included in the statistical analyses of PK parameters.	hours	MEAN
SECONDARY	Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)	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.	29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values \< than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.	hours	MEAN
SECONDARY	Population PK of Dasatinib	Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.		Population PK analysis	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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