Trial · NCT00924352
Trial of Dasatinib Plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer
NCT00924352, Phase 1, Phase 2, Completed, Accelerated Community Oncology Research Network; results first posted 2014-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Dasatinib Plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer. Trials, record NCT00924352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00924352
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Dasatinib Plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer
- NCT number
- NCT00924352
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Accelerated Community Oncology Research Network
- Conditions
- Metastatic Breast Cancer
- Interventions
- Dasatinib, Ixabepilone
- First posted
- 2009-06-18
- Last updated
- 2014-10-13
- Results first posted
- 2014-09-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I) | MTD was assessed during the first cycle of combination therapy (days 1-28). | The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT. |
| Primary | Determination of the Maximum Tolerated Dose (MTD) of Ixabepilone When Given in Combination With Dasatinib (Phase I) | MTD was assessed during the first cycle of combination therapy (days 1-28). | The MTD of ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) when given in combination with dasatinib (taken daily, continuously) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT. |
| Primary | Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I) | DLTs were assessed during the first cycle of combination therapy (days 1-28). | DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose limiting toxicity was defined as any grade 4 hematologic event or any grade 3 or 4 non-hematologic event occurring during cycle 1 that is attributable to dasatinib, ixabepilone, or the combination. The following events were excluded from this definition: grade 4 neutropenia lasting for 3 days or less; grade 3 nausea responsive to antiemetics; grade 3 infection with normal ANC or grade 1 or 2 neutrophils; grade 3 diarrhea responsive to optimal use of antidiarrheal therapy. |
| Primary | Evaluation of Progression-free Survival (PFS) of the Combination of Dasatinib and Ixabepilone (Phase II) | PFS was measured from day 1 of treatment until time of progression (assessed about every 8 weeks) or death, whichever came first, for up to 27.2 months. | Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. |
| Secondary | Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II) | Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months. | Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. |
| Secondary | Clinical Benefit Rate of the Combination of Dasatinib and Ixabepilone (Phase II) | Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months. | Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks (from the start of treatment) plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of \>=20%. |
| Secondary | Incidence of Grade 3 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II) | Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment. | All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 |
| Secondary | Incidence of Grade 4 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II) | Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment. | All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I) | MTD was assessed during the first cycle of combination therapy (days 1-28). | The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study. | mg daily | NUMBER |
| PRIMARY | Determination of the Maximum Tolerated Dose (MTD) of Ixabepilone When Given in Combination With Dasatinib (Phase I) | MTD was assessed during the first cycle of combination therapy (days 1-28). | The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study. | mg/m2 | NUMBER |
| PRIMARY | Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I) | DLTs were assessed during the first cycle of combination therapy (days 1-28). | The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study. | participants | NUMBER |
| SECONDARY | Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II) | Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months. | The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study. | participants | NUMBER |
| SECONDARY | Clinical Benefit Rate of the Combination of Dasatinib and Ixabepilone (Phase II) | Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months. | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Grade 3 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II) | Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment. | The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study. | participants | NUMBER |
| SECONDARY | Incidence of Grade 4 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II) | Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment. | The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study. | participants | NUMBER |
| PRIMARY | Evaluation of Progression-free Survival (PFS) of the Combination of Dasatinib and Ixabepilone (Phase II) | PFS was measured from day 1 of treatment until time of progression (assessed about every 8 weeks) or death, whichever came first, for up to 27.2 months. | The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I) | Ixabepilone + Dasatinib | 100 | mg daily | ||
| Determination of the Maximum Tolerated Dose (MTD) of Ixabepilone When Given in Combination With Dasatinib (Phase I) | Ixabepilone + Dasatinib | 20 | mg/m2 | ||
| Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I) | Ixabepilone + Dasatinib (Dose Level 0) | DLT: Grade 4 Thrombocytopenia | 0 | participants | |
| Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I) | Ixabepilone + Dasatinib (Dose Level 1) | DLT: Grade 4 Thrombocytopenia | 0 | participants | |
| Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I) | Ixabepilone + Dasatinib (Dose Level 2) | DLT: Grade 4 Thrombocytopenia | 1 | participants | |
| Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I) | Ixabepilone + Dasatinib (Dose Level 0) | DLT: Grade 4 Leukopenia | 0 | participants | |
| Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I) | Ixabepilone + Dasatinib (Dose Level 1) | DLT: Grade 4 Leukopenia | 0 | participants | |
| Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I) | Ixabepilone + Dasatinib (Dose Level 2) | DLT: Grade 4 Leukopenia | 1 | participants | |
| Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II) | Ixabepilone + Dasatinib | Complete Response | 0 | participants | |
| Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II) | Ixabepilone + Dasatinib | Partial Response | 4 | participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I | 12 | |
| Overall Study | STARTED | Phase II | 44 | |
| Overall Study | COMPLETED | Phase I | 12 | |
| Overall Study | COMPLETED | Phase II | 44 | |
| Overall Study | NOT COMPLETED | Phase I | 0 | |
| Overall Study | NOT COMPLETED | Phase II | 0 |
Source ClinicalTrials.gov
Adverse events185
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Ixabepilone + Dasatinib | 29 | 56 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ixabepilone + Dasatinib | 5 | 56 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ixabepilone + Dasatinib | 20 | 56 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ixabepilone + Dasatinib | 8 | 56 | |
| other | White Blood Cell Disorder | Blood and lymphatic system disorders | Ixabepilone + Dasatinib | 1 | 56 | |
| other | Palpitations | Cardiac disorders | Ixabepilone + Dasatinib | 3 | 56 | |
| other | Sinus Tachycardia | Cardiac disorders | Ixabepilone + Dasatinib | 1 | 56 | |
| other | Ear Pain | Ear and labyrinth disorders | Ixabepilone + Dasatinib | 1 | 56 | |
| other | Eye Irritation | Eye disorders | Ixabepilone + Dasatinib | 1 | 56 | |
| other | Eyelid Edema | Eye disorders | Ixabepilone + Dasatinib | 1 | 56 |
1 to 10 of 185Source ClinicalTrials.gov
See all 185 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixabepilone + Dasatinib | ||
| Total, other adverse events | Ixabepilone + Dasatinib | 56 | 56 |
| Total, serious adverse events | Ixabepilone + Dasatinib | 11 | 56 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00924352
GET https://conductscience.org/api/trials/v1/NCT00924352/events?page=2