| Primary | Number of Participants With Objective Response | Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR. | 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). | Posted | | Number | | participants | | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | | | | ID | Title | Description |
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| OG000 | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg. | | OG001 | Her2/Neu-amplified Tumor, 100 mg BID | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg. | | OG002 | ER and/or PgR Positive Tumor, 70 mg BID Dasatinib | Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg. | | OG003 | ER and/or PgR Positive Tumor, 100 mg BID Dasatinib | Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg. |
| | Units | Counts |
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| Participants | - OG00015
- OG0019
- OG00231
- OG003
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| | Title | Denominators | Categories |
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| Primary | Percentage of Participants With Objective Response | Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. | 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). | Posted | | Number | 95% Confidence Interval | percentage of participants | | From day of first treatment through Week 25 or at time of discontinuation from study treatment | | | | ID | Title | Description |
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| OG000 | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg. | | OG001 | Her2/Neu-amplified Tumor, 100 mg BID Dasatinib | |
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| Secondary | Number of Response-evaluable Participants With Disease Control (DCR) | Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks. | 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). | Posted | | Number | | participants | | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | | | | ID | Title | Description |
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| OG000 | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg. | | OG001 | Her2/Neu-amplified Tumor, 100 mg BID Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg. |
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| Secondary | Percentage of Response-evaluable Participants With Disease Control (DCR) | Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks. | 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). | Posted | | Mean | 95% Confidence Interval | percentage of participants | | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | | | | ID | Title | Description |
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| OG000 | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg. | | OG001 | Her2/Neu-amplified Tumor, 100 mg BID Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg. |
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| Secondary | Number of Participants Who Progressed | PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed. | All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks. | Posted | | Number | | participants | | From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45) | | | | ID | Title | Description |
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| OG000 | Her2/Neu-amplified Tumor | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID). | | OG001 | ER and/or PgR Positive Tumor | Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally dasatinib twice daily (BID). | | OG002 | All Participants | Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg). |
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| Secondary | Median Progression Free Survival (PFS) | PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed. | All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks. | Posted | | Median | 95% Confidence Interval | weeks | | From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45) | | | | ID | Title | Description |
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| OG000 | Her2/Neu-amplified Tumor | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID). | | OG001 | ER and/or PgR Positive Tumor | Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally dasatinib twice daily (BID). |
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| Secondary | Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25 | PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed. | 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). | Posted | | Number | | percentage of participants | | At Weeks 9, 17, and 25 | | | | ID | Title | Description |
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| OG000 | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg. | | OG001 | Her2/Neu-amplified Tumor, 100 mg BID Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg. |
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| Secondary | Duration Of Objective Response | Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment. | Of 69 response-evaluable participants, three had an objective response of PR. | Posted | | Number | | weeks | | the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed | | | | ID | Title | Description |
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| OG000 | Participant CA180088-18-88009, HER-2 Group | Participant with Human epidermal growth factor (Her2/neu)-amplified tumor type (also positive for ER and PgR) who received 100 mg dasatinib BID. | | OG001 | Participant CA180088-16-88002, ER and/or PgR Group | Participant with ER and PgR-amplified tumor type who received 100 mg dasatinib BID | | OG002 | Participant CA180088-29-88085, ER and/or PgR Group | Participant with ER and PgR-amplified tumor type who received 70 mg dasatinib BID |
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| Secondary | Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. | All-Treated participants: All participants who received at least one dose of dasatinib. | Posted | | Number | | participants | | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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| Secondary | Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities | Normal ranges for laboratory abnormalities: granulocytes=1.5x10^3-8x10^3 mm^3 (range may have varied by institution); hemoglobin=12-16 g/dL; platelets=150-440x10^9c/L; partial thromboplastin time=27-37.1 seconds; alkaline phosphatase=38-126 U/L; alanine aminotransferase=15-48 U/L; aspartate aminotransferase=14-38 U/L; creatine=0.7-1.1 mg/dL; hypokalemia (potassium [K])=3.5-5mEq/L; hyponatremia (sodium [Na])=135-145 mEq/L; phosphorous=2.4-4.5 mg/dL; bilirubin=0-1.2. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening/disabling, Gr 5=Death. | All-Treated participants: All participants who received at least one dose of dasatinib. | Posted | | Number | | participants | | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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| Secondary | Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs | AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to CTCAE Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. | All-Treated participants: All participants who received at least one dose of dasatinib. | Posted | | Number | | participants | | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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| Secondary | Number Of Participants With Notable Drug-related AEs | Notable drug-related AEs for dasatinib include gastrointestinal symptoms (diarrhea, nausea, vomiting and abdominal pain), fatigue, lethargy, headache, rash, fever, pleural effusion, and dyspnea. | All-Treated participants: All participants who received at least one dose of dasatinib. | Posted | | Number | | participants | | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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| Secondary | Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3 | Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites. | 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 | Posted | | Mean | Standard Deviation | ng/ml | | 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). | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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| Secondary | PK: Plasma Concentration of Dasatinib at Week 7 or Week 9 | Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites. | 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 | Posted | | Mean | Standard Deviation | ng/ml | | 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). | | | | ID | Title | Description |
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| OG000 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. | | OG001 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG002 | Dasatinib 50 mg | Dasatinib was administered orally at a starting dose of 70 mg BID. Dose adjustment was made according to tolerance, with reduction to 50 mg BID. Participants continued study treatment until PD or unacceptable toxicity. Dasatinib dose was adjusted so that drug-related toxicities were either Grade 0 - 1 or were Grade 2 toxicities that were adequately managed with outpatient therapy or deemed clinically acceptable. |
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| Secondary | Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR | Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA. | 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 | Posted | | Mean | 90% Confidence Interval | percent change | | At Baseline and Week 3 of treatment (Day 15 ±4 days) | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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| Secondary | Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR | Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA. | 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 | Posted | | Mean | 90% Confidence Interval | percent change | | Week 5 | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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| Secondary | Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR | VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation. | 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 | Posted | | Mean | 90% Confidence Interval | percent change | | At Baseline and Week 3 of treatment (Day 15 ±4 days) | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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| Primary | Best Overall Response | Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD. | 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). | Posted | | Number | | participants | | From day of first treatment through Week 25 or at time of discontinuation from study treatment | | | | ID | Title | Description |
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| OG000 | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg. | | OG001 | Her2/Neu-amplified Tumor, 100 mg BID |
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| Secondary | Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR | VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation. | 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 | Posted | | Mean | 90% Confidence Interval | percent change | | At Baseline and Week 5 of treatment | | | | ID | Title | Description |
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| OG000 | Dasatinib 70 mg | Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg. | | OG001 | Dasatinib 100 mg | Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg. |
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