Trial · NCT00820170
Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194
NCT00820170, Phase 1, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2019-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194. Trials, record NCT00820170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00820170
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194
- NCT number
- NCT00820170
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Breast Cancer
- Interventions
- Dasatinib and Paclitaxel
- First posted
- 2009-01-12
- Last updated
- 2019-08-13
- Results first posted
- 2019-08-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel. | Through completion of Phase I, up to 1 year | |
| Primary | Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Through study completion, up to 2 years | |
| Secondary | Median Overall Survival for Phase II Participants | Through study completion, up to 2 years | Overall Survival for Phase II Participants |
| Secondary | Participant Adverse Events to Measure Safety and Tolerability of Dasatinib When Administered in Combination With Weekly Paclitaxel. | Through study completion, up to 2 years | Evaluate adverse events using CTCAE v3 |
| Secondary | Median Progression Free Survival for Phase II Participants | Through study completion, up to 2 years | Per RECIST criteria, Progression (PD) is defined at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Phase II: Number of Participants With Clinical Benefit According to Tumor Biomarker Data: Assays of VEGFR2 | 8 weeks | Tumor biomarker data obtained at baseline and after 2 cycles of treatment (8 weeks), will be performed by enzyme-linked immunosorbent assay. Clinical Benefit is defined as the sum of the percentage of participants who achieved CR, PR and stable disease for \> 6 months. |
| Secondary | Median Time To Progression for Phase II Participants | Through study completion, up to 2 years | |
| Secondary | Phase II: Number of Participants With Clinical Benefit According to Circulating Tumor Cells (CTC) at Baseline and After 2 Cycles of Treatment (8 Weeks) | 8 weeks | Phase II participants only |
| Secondary | Phase II: Exploratory Somatic Gene Mutations Detection in Archived Tumor Samples | 2 years |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel. | Through completion of Phase I, up to 1 year | 15 participants were enrolled for the Phase I portion of the study. These 15 participants determined the MTD for the study. | mg of dasatinib | NUMBER |
| PRIMARY | Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Through study completion, up to 2 years | The 3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study. Results and data analysis reflect this. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Overall Survival for Phase II Participants | Through study completion, up to 2 years | This objective is specific for the Phase II participants | months | MEDIAN |
| SECONDARY | Participant Adverse Events to Measure Safety and Tolerability of Dasatinib When Administered in Combination With Weekly Paclitaxel. | Through study completion, up to 2 years | The 3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression Free Survival for Phase II Participants | Through study completion, up to 2 years | This objective is specific for the Phase II participants | months | MEDIAN |
| SECONDARY | Phase II: Number of Participants With Clinical Benefit According to Tumor Biomarker Data: Assays of VEGFR2 | 8 weeks | Phase II participants only | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time To Progression for Phase II Participants | Through study completion, up to 2 years | This objective is specific for the Phase II participants | months | MEDIAN |
| SECONDARY | Phase II: Number of Participants With Clinical Benefit According to Circulating Tumor Cells (CTC) at Baseline and After 2 Cycles of Treatment (8 Weeks) | 8 weeks | Phase II participants only | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase II: Exploratory Somatic Gene Mutations Detection in Archived Tumor Samples | 2 years | Data were not collected |
Source ClinicalTrials.gov
Results by group79
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel. | Dasatinib and Paclitaxel | 120 | mg of dasatinib | ||
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | Stable Disease | 3 | Participants | |
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | Stable Disease | 1 | Participants | |
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | Stable Disease | 1 | Participants | |
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | Stable Disease | 15 | Participants | |
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | No Arm Selected | Stable Disease | 1 | Participants | |
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | Complete Response | 0 | Participants | |
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | Complete Response | 0 | Participants | |
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | Complete Response | 0 | Participants | |
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial. | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | Complete Response | 1 | Participants |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 3 | |
| Overall Study | STARTED | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 5 | |
| Overall Study | STARTED | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 3 | |
| Overall Study | STARTED | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 40 | |
| Overall Study | STARTED | Participants Who Did Not Receive Treatment | 4 | |
| Overall Study | COMPLETED | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 3 | |
| Overall Study | COMPLETED | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 5 | |
| Overall Study | COMPLETED | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 3 | |
| Overall Study | COMPLETED | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 40 | |
| Overall Study | COMPLETED | Participants Who Did Not Receive Treatment | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events285
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 | ALT, SGPT | Investigations | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 1 | 3 | |
| other | ALT, SGPT | Investigations | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 1 | 5 | |
| other | ALT, SGPT | Investigations | Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 0 | 3 | |
| other | ALT, SGPT | Investigations | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 6 | 40 | |
| other | ALT, SGPT | Investigations | No Arm Selected | 0 | 4 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 1 | 3 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 1 | 5 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 0 | 3 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 1 | 40 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | No Arm Selected | 0 | 4 |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 3 | 3 |
| Total, all-cause mortality | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 5 | 5 |
| Total, all-cause mortality | Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 3 | 3 |
| Total, all-cause mortality | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 5 | 40 |
| Total, all-cause mortality | No Arm Selected | 4 | 4 |
| Total, other adverse events | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 3 | 3 |
| Total, other adverse events | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 5 | 5 |
| Total, other adverse events | Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 2 | 3 |
| Total, other adverse events | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 40 | 40 |
| Total, other adverse events | No Arm Selected | 0 | 4 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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/NCT00820170
GET https://conductscience.org/api/trials/v1/NCT00820170/results?page=2