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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract No: 2005-004864-22 |
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Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin | Experimental | Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
|
| 30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin | Experimental | Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
|
| 35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin | Experimental | Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Dose Limiting Toxicity (DLT) | DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks | From Baseline to the end of Cycle 1 (Day 21) |
| Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) | The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD. | Day 21 of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation | AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (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/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Toulouse | 31052 | France | |||
| Local Institution |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2 | Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| FG001 | Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2 | Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| FG002 | Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2 | Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| FG003 | All Participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
| |||||||||||||
| Starting Dose |
| |||||||||||||
| First Escalation |
| |||||||||||||
| Second Escalation |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2 | Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| BG001 | Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 a Dose Limiting Toxicity (DLT) | DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks | The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and was observed for ≥21 days following the first dose or the participant experienced DLT. | Posted | Number | Participants | From Baseline to the end of Cycle 1 (Day 21) |
|
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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 | Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2 | Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PLATELET COUNT DECREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONJUNCTIVITIS | Eye disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
| D034261 | Epothilones |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Epirubicin | Drug | Infusion, intravenous (IV): 75 mg/m^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m². |
|
| Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug. |
| Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone | Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
| Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2. | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
| Terminal Half-life (T-Half) of Single-dose Ixabepilone | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
| Clearance (CLT) of Single-dose Ixabepilone | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
| Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
| Epirubicin Cmax | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
| Epirubicin AUC(INF) | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=the area under the plasma concentration-time curve from time zero extrapolated to infinity of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
| Epirubicin T-Half | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of epirubicin administered IV dose 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
| Epirubicin CLT | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
| Epirubicin Vss | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
| Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease | Information on all tumor lesions was obtained at baseline by radiologic techniques, or if appropriate by physical examination (e.g. subcutaneous nodules). Measurable tumors were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, wherein complete response (CR) = disappearance of all target lesions; partial response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD)= ≥20% increase in the sum of the longest diameter of target lesions, and stable disease (SD) = small changes that do not meet above criteria. | From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2 |
| Duration of Tumor Response | Defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death. CR= disappearance of all target lesions; PR= ≥30% decrease in the sum of the longest diameter of target lesions. | Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease. |
| Number Of Participants With Tumor Response by Duration of Response Category | Duration of response was defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death; PR= ≥30% decrease in the sum of the longest diameter of target lesions. | Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease. |
| Milan |
| 20133 |
| Italy |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| BG002 | Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2 | Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2 |
Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| OG001 | Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2 | Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
| OG002 | Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2 | Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. |
|
|
| Primary | Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) | The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD. | The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and were observed for ≥21 days following the first dose or the participant experienced DLT. | Posted | Number | mg^m2 | Day 21 of Cycle 1 |
|
|
|
| Secondary | Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation | AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (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/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event | All participants who received at least 1 cycle of therapy were evaluable for safety; adverse events and other symptoms were graded according to CTCAE Version 3.0. | Posted | Number | participants | Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug. |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone | Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | ng/ml | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
|
|
|
| Secondary | Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | ng·h/mL | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
|
|
|
| Secondary | Terminal Half-life (T-Half) of Single-dose Ixabepilone | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | hours | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
|
|
|
| Secondary | Clearance (CLT) of Single-dose Ixabepilone | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | L/h | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | liters | From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. |
|
|
|
| Secondary | Epirubicin Cmax | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | ng/ml | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
|
|
|
| Secondary | Epirubicin AUC(INF) | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=the area under the plasma concentration-time curve from time zero extrapolated to infinity of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | ng·h/mL | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
|
|
|
| Secondary | Epirubicin T-Half | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of epirubicin administered IV dose 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | hours | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
|
|
|
| Secondary | Epirubicin CLT | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | L/h | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
|
|
|
| Secondary | Epirubicin Vss | PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. | Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles. | Posted | Mean | Standard Deviation | liters | From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. |
|
|
|
| Secondary | Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease | Information on all tumor lesions was obtained at baseline by radiologic techniques, or if appropriate by physical examination (e.g. subcutaneous nodules). Measurable tumors were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, wherein complete response (CR) = disappearance of all target lesions; partial response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD)= ≥20% increase in the sum of the longest diameter of target lesions, and stable disease (SD) = small changes that do not meet above criteria. | Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions. | Posted | Number | participants | From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2 |
|
|
|
| Secondary | Duration of Tumor Response | Defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death. CR= disappearance of all target lesions; PR= ≥30% decrease in the sum of the longest diameter of target lesions. | Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions. | Posted | Median | Full Range | months | Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease. |
|
|
|
| Secondary | Number Of Participants With Tumor Response by Duration of Response Category | Duration of response was defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death; PR= ≥30% decrease in the sum of the longest diameter of target lesions. | Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions. | Posted | Number | participants | Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease. |
|
|
|
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2 | Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. | 8 | 30 | 30 | 30 |
| EG002 | Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2 | Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. | 1 | 6 | 6 | 6 |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| VENOUS INSUFFICIENCY | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| AREFLEXIA | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| DYSAESTHESIA | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| HYPOREFLEXIA | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| SENSORY LOSS | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| HYPOAESTHESIA | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| HYPERAESTHESIA | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| CRANIAL NEUROPATHY | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| GINGIVAL PAIN | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| ONYCHOMYCOSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| DYSURIA | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| BLISTER | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| BARTHOLINITIS | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 11.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 11.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 11.1 | Systematic Assessment |
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| HYPERTHERMIA | General disorders | MedDRA 11.1 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA 11.1 | Systematic Assessment |
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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.
| D017437 |
| Skin and Connective Tissue Diseases |
| D004317 |
| Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
|
| AEs |
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| SAEs |
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| Grade 3/4 AEs |
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| AEs leading to discontinuation of study treatment |
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| Stable Disease |
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| Progressive Disease |
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| Response Duration ≥6 Months |
|