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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT: 2006-006973-26 |
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The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg BID dasatinib + 825 mg/m^2 BID capecitabine | Experimental | Twice a day (BID) for 2 weeks of a 3-week cycle |
|
| 70 mg BID dasatinib + 825 mg/m^2 BID capecitabine | Experimental | BID for 2 weeks of a 3-week cycle |
|
| 70 mg BID dasatinib + 1000 mg/m^2 BID capecitabine | Experimental | BID for 2 weeks of a 3-week cycle |
|
| 100 mg QD dasatinib + 1000 mg/m^2 BID capecitabine | Experimental | 2 weeks of a 3-week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population | 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. | Day 1 to 30 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | 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. |
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For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Of Hope National Medical Center | Duarte | California | 91010-3000 | United States | ||
| Northwestern University Feinberg School Of Medicine |
57 enrolled and 52 treated. Reasons for not being treated: 4 no longer met criteria; 1 administrative reason by sponsor. Drug was administered at a reduced dose (gradually escalating at each dose level) during the escalation period and then once a dose for the expansion cohort was identified, additional participants were treated with this dose.
28 Jan 2007 to 30 Oct 2012. Women with advanced breast cancer (ABC) were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 50 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation) | Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group. |
| FG001 | 70 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation) | Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID. |
| FG002 | 70 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation) | Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID. |
| FG003 | 100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation) | Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment. |
| FG004 | 100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Expansion) | No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for the dose expansion period in order to provide additional information regarding good tolerance of extended treatment. An additional 21 participants were treated in this arm in the Dose Expansion Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation Period |
|
| ||||||||||||||||||
| Dose Expansion Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 50 mg Dasatinib + 825 mg/m^2Capecitabine | Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population | 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. | 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. | Posted | Number | participants | Day 1 to 30 days post last dose |
Day 1 up to 30 days post last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 50 mg Dasatinib + 825 mg/m^2 Capecitabine | Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
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Not provided
|
| Capecitabine | Drug | Tablets, Oral, 660 - 1250 mg/m^2 twice a day (BID). Treatment may continue until disease progression. |
|
|
| Day 1 up to 30 days post last dose |
| Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population | 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. | Day 1 to 30 days post last dose |
| Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population | 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. | Day 1 up to 30 days post last dose |
| 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 | 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:\ | Day 1 up to 30 days post last dose |
| 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 | 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:\ | Day 1 to 30 days post last dose |
| Chicago |
| Illinois |
| 60611 |
| United States |
| New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States |
| Local Institution | Rozzano | Milano | 20089 | Italy |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Seville | 41013 | Spain |
| study drug toxicity |
|
| Other |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 70 mg Dasatinib + 825 mg/m^2Capecitabine | Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID. |
| BG002 | 70 mg Dasatinib + 1000 mg/m^2Capecitabine | Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID. |
| BG003 | 100 mg Dasatinib + 1000 mg/m^2Capecitabine | Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 50 mg Dasatinib + 825 mg/m^2Capecitabine | Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group. |
| OG001 | 70 mg Dasatinib + 825 mg/m^2Capecitabine | Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID. |
| OG002 | 70 mg Dasatinib + 1000 mg/m^2Capecitabine | Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID. |
| OG003 | 100 mg Dasatinib + 1000 mg/m^2Capecitabine | Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment. |
|
|
| Secondary | Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population | 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. | Safety Population: all participants receiving at least one dose of study drug. | Posted | Number | participants | Day 1 up to 30 days post last dose |
|
|
|
| Secondary | Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population | 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. | 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. | Posted | Number | participants | Day 1 to 30 days post last dose |
|
|
|
| Secondary | Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 up to 30 days post last dose |
|
|
|
| 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 | 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:\ | 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. | Posted | Number | participants | Day 1 up to 30 days post last dose |
|
|
|
| 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 | 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:\ | 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. | Posted | Number | participants | Day 1 to 30 days post last dose |
|
|
|
| 2 |
| 7 |
| 7 |
| 7 |
| EG001 | 70 mg Dasatinib + 825 mg/m^2 Capecitabine | Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID. | 2 | 9 | 9 | 9 |
| EG002 | 70 mg Dasatinib + 1000 mg/m^2 Capecitabine | Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID. | 4 | 6 | 6 | 6 |
| EG003 | 100 mg Dasatinib + 1000 mg/m^2 Capecitabine | Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment. | 13 | 30 | 30 | 30 |
| Mucosal inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Facial neuralgia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophil count | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Plantar erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| QRS axis abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Deaths reported beyond 30 days post last dose |
|
| Participants with SAEs |
|
| Participants with Grade 3 - 4 SAEs |
|
| Participants with AEs |
|
| AEs leading to discontinuation of therapy |
|
| Participants with study drug-related AEs |
|
| Unconfirmed partial response |
|
| Partial Response |
|
| Stable Disease |
|
| Progressive Disease |
|
| Clinical Progression |
|
| Discontinuation due to study drug toxicity |
|
| Disease control rate |
|
| ANC (N=6, 9, 6, 30) |
|
| Platelet Count (N=7, 9, 6, 30) |
|
| Hemoglobin (N=7, 6, 4, 18) |
|
| Alanine Aminotransferase (N=6, 9, 6, 25) |
|
| Aspartate Aminotransferase (N=4, 8, 6, 25) |
|
| Total Bilirubin (N=6, 9, 6, 29) |
|