Trial · NCT00101816
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | All treated subjects | Participants | NUMBER |
| SECONDARY | Median Duration of Major Hematologic Response (MaHR) | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | Participants who achieved MaHR | months | MEDIAN |
| SECONDARY | Median Duration of Overall Hematologic Response (OHR) | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | Participants who achieved OHR | months | MEDIAN |
| SECONDARY | Time to MaHR and OHR | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment | Participants who achieved OHR and MaHR | days | MEDIAN |
| SECONDARY | Number of Participants With Complete, Partial, Minor, Minimal, or No 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 | Number of Participants With CHR or NEL, MiHR, or no Hematologic Response | Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment | All treated subjects | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving Major Molecular Response (MMR) | Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis | treated participants with or without CCyR who were assessed for major molecular response | participants | NUMBER |
| SECONDARY | MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations | baseline, at time of disease progression | All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 103 of the 109 subjects (10/10 imatinib-intolerant and 93/99 imatinib-resistant). At baseline, 39 (42%) imatinib-resistant subjects and 3 imatinib-intolerant subject had imatinib-resistant mutations | Percentage of Participants | NUMBER |
| SECONDARY | Minimally Significant Changes 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 | Number of participants with FACT-G assessments at baseline and at least one assessment during treatment | Participants | NUMBER |
| SECONDARY | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs | Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period | All treated subjects | Participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK) of Dasatinib - 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. | 26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was 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 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(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. | 26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was 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 - 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. | 26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was 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 | Pharmacokinetics (PK) of Dasatinib - 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. | 26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was 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 | Pharmacokinetics (PK) of Dasatinib's 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. | 26 participants had dense PK sampling on Day 1 \& Day 8; parameters for 1 participant on Day 1 \& 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values \<than 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's 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 h (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. | 26 participants had dense PK sampling on Day 1 \& Day 8; parameters for 1 participant on Day 1 \& 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values \<than 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's 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. | 26 participants had dense PK sampling on Day 1 \& Day 8; parameters for 1 participant on Day 1 \& 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values \<than 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 | 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. | 26 participants had dense PK sampling on Day 1 \& Day 8; parameters for 1 participant on Day 1 \& 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values \<than 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 | 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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