Trial · NCT00371345
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 | Number of Participants With Objective Response | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment. One participant was not evaluable (no on-study tumor assessment for other reason). | participants | NUMBER |
| PRIMARY | Percentage of Participants With Objective Response | From day of first treatment through Week 25 or at time of discontinuation from study treatment | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | percentage of participants | NUMBER |
| SECONDARY | Number of Response-evaluable Participants With Disease Control (DCR) | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | participants | NUMBER |
| SECONDARY | Percentage of Response-evaluable Participants With Disease Control (DCR) | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | percentage of participants | MEAN |
| SECONDARY | Number of Participants Who Progressed | From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45) | All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks. | participants | NUMBER |
| SECONDARY | Median Progression Free Survival (PFS) | From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45) | All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25 | At Weeks 9, 17, and 25 | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | percentage of participants | NUMBER |
| SECONDARY | Duration Of Objective Response | the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed | Of 69 response-evaluable participants, three had an objective response of PR. | weeks | NUMBER |
| SECONDARY | Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | All-Treated participants: All participants who received at least one dose of dasatinib. | participants | NUMBER |
| SECONDARY | Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | All-Treated participants: All participants who received at least one dose of dasatinib. | participants | NUMBER |
| SECONDARY | Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | All-Treated participants: All participants who received at least one dose of dasatinib. | participants | NUMBER |
| SECONDARY | Number Of Participants With Notable Drug-related AEs | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | All-Treated participants: All participants who received at least one dose of dasatinib. | participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3 | PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours). | Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis | ng/ml | MEAN |
| SECONDARY | PK: Plasma Concentration of Dasatinib at Week 7 or Week 9 | PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours). | Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis | ng/ml | MEAN |
| SECONDARY | Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR | At Baseline and Week 3 of treatment (Day 15 ±4 days) | Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis | percent change | MEAN |
| SECONDARY | Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR | Week 5 | Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis | percent change | MEAN |
| SECONDARY | Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR | At Baseline and Week 3 of treatment (Day 15 ±4 days) | Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis | percent change | MEAN |
| PRIMARY | Best Overall Response | From day of first treatment through Week 25 or at time of discontinuation from study treatment | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | participants | NUMBER |
| SECONDARY | Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR | At Baseline and Week 5 of treatment | Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis | percent change | MEAN |
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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