Trial · NCT00452673
Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer
NCT00452673, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2013-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer. Trials, record NCT00452673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00452673
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer
- NCT number
- NCT00452673
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 52 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Breast Cancer
- Interventions
- Dasatinib, Capecitabine
- First posted
- 2007-03-27
- Last updated
- 2015-03-24
- Other registries' IDs
- eudract:2006-006973-26
- Results first posted
- 2013-12-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population | Day 1 to 30 days post last dose | Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade \>= 3, or of Grade 2 which required interruption of treatment for \>= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade \>= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy. |
| Secondary | Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | Day 1 up to 30 days post last dose | Adverse events (AEs) were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious AE (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. |
| Secondary | Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population | Day 1 to 30 days post last dose | Complete Response (CR): disappearance of all target and non-target lesions, with confirmation at \>=4 weeks interval; Partial Response (PR): \>= 30% decrease in sum of longest diameter (LDs) of target lesions, taking as reference the baseline sum LD, with confirmation at \>= 4 weeks interval. Progressive Disease (PD): Appearance of new lesion(s), or \>=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, without unequivocal progression of non-target lesions, after \>=6 weeks on study. Radiological tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) occurred every 6 weeks. For those patients who were on treatment \> 24 weeks, the tumor assessment occurred every 9 weeks. |
| Secondary | Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population | Day 1 up to 30 days post last dose | Objective response rate was the percentage of participants, (n/N; number with objective response per Number evaluated) whose best response is either a Complete Response (CR) or a Partial Response (PR). Disease control rate was defined as percentage (n/N) of participants with stable disease greater than (\>) 6 months, PR, or CR. Efficacy Evaluable Population: All participants with at least one measurable lesion at baseline, who received at least one dose of combination study drug and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stop treatment prior to tumor assessment for reasons unrelated to disease or drug were excluded. |
| Secondary | Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population | Day 1 up to 30 days post last dose | National Cancer Institute Common terminology criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN). CTC criteria: Absolute neutrophil count (ANC). Leukocytes (White blood cells) Grade (Gr) 1:\<LLN to 3.0\*10\^9/L, Gr 2:\<3.0 to 2.0\*10\^9/L, Gr 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. ANC Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.0\*10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Participants with a baseline hematology lab value of Gr 0 but who had Gr 3 - 4 hematology value while on-study are presented below. |
| Secondary | Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population | Day 1 to 30 days post last dose | CTC, Version 3 used to assess parameters. (ULN)=upper limit of normal: (ALT)= alanine transaminase; (AST)=aspartate aminotransferase; (ALP)=alkaline phosphatase. ALT Grade (Gr)1:\>ULN to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. AST Gr 1: \>ULN to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Total bilirubin Gr 1: \>ULN to 1.5\*ULN; Gr 2: \>1.5 to 3.0\*ULN; Gr 3: \>3.0 to 10.0\*ULN; Gr 4: \>10.0\*ULN. ALP (U/L) Gr1:\>ULN to 2.5\*ULN, Gr2:\>2.5 to 5.0\*ULN, Gr3:\>5.0 to 20.0\*ULN, Gr4:\>20.0\*ULN. Albumin (low) Gr 1:\<LLN - 3 grams per deciliter (g/dL)to \<LLN - 3 g/dL; Gr 2: \<3 - 2 g/dL to \< 3.0 - 2.0 g/dL; Gr 3: \< 2 g/dL to \<2 g/L. Participants with a baseline chemistry lab value of Gr 0 but who had Gr 3 - 4 chemistry value while on-study are presented below. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population | Day 1 to 30 days post last dose | Safety Population: All participants who received at least one dose of study drug. DLTs: Grade 3 headache, Grade 3 pneumonia, Grade 3 diarrhea in Dosing arms, 1, 2, and 3, respectively. DLTs in dose arm 4: 1 participant with Grade 3 pneumonia and pain and 1 participant with Grade 4 neutropenia and diarrhea plus Grade 3 vomiting and mucositis. | participants | NUMBER |
| SECONDARY | Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | Day 1 up to 30 days post last dose | Safety Population: all participants receiving at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population | Day 1 to 30 days post last dose | All participants with at least one measurable lesion at baseline, who received at least one dose of the combination therapy and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stopped drug prior to tumor assessment for reasons unrelated to disease or drug were excluded. | participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population | Day 1 up to 30 days post last dose | n=number of participants with ORR: 2, 1, 0, 6 in dosing arms 1, 2, 3, and 4, respectively. n= number of participants with Disease control: 3, 2, 2, 14 in dosing arms 1, 2, 3, and 4, respectively. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population | Day 1 up to 30 days post last dose | Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively. | participants | NUMBER |
| SECONDARY | Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population | Day 1 to 30 days post last dose | Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population | 50 mg Dasatinib + 825 mg/m^2Capecitabine | 1 | participants | ||
| Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population | 70 mg Dasatinib + 825 mg/m^2Capecitabine | 1 | participants | ||
| Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population | 70 mg Dasatinib + 1000 mg/m^2Capecitabine | 1 | participants | ||
| Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population | 100 mg Dasatinib + 1000 mg/m^2Capecitabine | 2 | participants | ||
| Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | 50 mg Dasatinib + 825 mg/m^2Capecitabine | Deaths within 30 days of last dose | 0 | participants | |
| Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | 70 mg Dasatinib + 825 mg/m^2Capecitabine | Deaths within 30 days of last dose | 0 | participants | |
| Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | 70 mg Dasatinib + 1000 mg/m^2Capecitabine | Deaths within 30 days of last dose | 0 | participants | |
| Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | 100 mg Dasatinib + 1000 mg/m^2Capecitabine | Deaths within 30 days of last dose | 0 | participants | |
| Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | 50 mg Dasatinib + 825 mg/m^2Capecitabine | Deaths reported beyond 30 days post last dose | 0 | participants | |
| Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | 70 mg Dasatinib + 825 mg/m^2Capecitabine | Deaths reported beyond 30 days post last dose | 0 | participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Period | STARTED | 50 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation) | 7 | |
| Dose Escalation Period | STARTED | 70 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation) | 9 | |
| Dose Escalation Period | STARTED | 70 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation) | 6 | |
| Dose Escalation Period | STARTED | 100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation) | 9 | |
| Dose Escalation Period | STARTED | 100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Expansion) | 0 | |
| Dose Escalation Period | COMPLETED | 50 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation) | 0 | |
| Dose Escalation Period | COMPLETED | 70 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation) | 0 | |
| Dose Escalation Period | COMPLETED | 70 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation) | 0 | |
| Dose Escalation Period | COMPLETED | 100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation) | 0 | |
| Dose Escalation Period | COMPLETED | 100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Expansion) | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events616
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 | Abdominal pain | Gastrointestinal disorders | 50 mg Dasatinib + 825 mg/m^2 Capecitabine | 2 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | 70 mg Dasatinib + 825 mg/m^2 Capecitabine | 1 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | 70 mg Dasatinib + 1000 mg/m^2 Capecitabine | 0 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | 100 mg Dasatinib + 1000 mg/m^2 Capecitabine | 3 | 30 | |
| other | Dysgeusia | Nervous system disorders | 50 mg Dasatinib + 825 mg/m^2 Capecitabine | 1 | 7 | |
| other | Dysgeusia | Nervous system disorders | 70 mg Dasatinib + 825 mg/m^2 Capecitabine | 1 | 9 | |
| other | Dysgeusia | Nervous system disorders | 70 mg Dasatinib + 1000 mg/m^2 Capecitabine | 0 | 6 | |
| other | Dysgeusia | Nervous system disorders | 100 mg Dasatinib + 1000 mg/m^2 Capecitabine | 5 | 30 | |
| other | Dysphonia | Respiratory, thoracic and mediastinal disorders | 50 mg Dasatinib + 825 mg/m^2 Capecitabine | 1 | 7 | |
| other | Dysphonia | Respiratory, thoracic and mediastinal disorders | 70 mg Dasatinib + 825 mg/m^2 Capecitabine | 0 | 9 |
1 to 10 of 616Source ClinicalTrials.gov
See all 616 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 50 mg Dasatinib + 825 mg/m^2 Capecitabine | ||
| Total, all-cause mortality | 70 mg Dasatinib + 825 mg/m^2 Capecitabine | ||
| Total, all-cause mortality | 70 mg Dasatinib + 1000 mg/m^2 Capecitabine | ||
| Total, all-cause mortality | 100 mg Dasatinib + 1000 mg/m^2 Capecitabine | ||
| Total, other adverse events | 50 mg Dasatinib + 825 mg/m^2 Capecitabine | 7 | 7 |
| Total, other adverse events | 70 mg Dasatinib + 825 mg/m^2 Capecitabine | 9 | 9 |
| Total, other adverse events | 70 mg Dasatinib + 1000 mg/m^2 Capecitabine | 6 | 6 |
| Total, other adverse events | 100 mg Dasatinib + 1000 mg/m^2 Capecitabine | 30 | 30 |
| Total, serious adverse events | 50 mg Dasatinib + 825 mg/m^2 Capecitabine | 2 | 7 |
| Total, serious adverse events | 70 mg Dasatinib + 825 mg/m^2 Capecitabine | 2 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT00452673
GET https://conductscience.org/api/trials/v1/NCT00452673/results?page=2