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The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixabepilone + Capecitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Experiencing Dose Limiting Toxicity (DLT) | DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles. | From initiation of drug through last day of Cycle 2 (Day 42) |
| Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) | The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity. | At the end of Cycle 2 (Day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. 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. Treatment-related=Possible, Probable, or Certain relationship to drug |
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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 | Matsuyama | Ehime | 7910280 | Japan | ||
| Local Institution |
Not provided
Participants were recruited from 4 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. |
| FG001 | Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | After receiving Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. |
| FG002 | Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | After receiving Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. |
| BG001 | Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Participants Experiencing Dose Limiting Toxicity (DLT) | DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles. | All participants who received at least 1 dose of either ixabepilone or capecitabine. | Posted | Number | Participants | From initiation of drug through last day of Cycle 2 (Day 42) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each treatment cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SKIN INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WEIGHT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Capecitabine | Drug | Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles |
|
| Baseline to Day 42, continuously |
| Participant Tumor Response at Study Endpoint | Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which 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. | At baseline and after every 42 days (every 2 21-day cycles) after baseline |
| Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval | Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval. | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
| Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval | AUC = the average area under the concentration curve (AUC [INF]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours. | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
| Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval | T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval. | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
| Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval | Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval. | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
| Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval | CLT = total body clearance as determined from participant serum samples in one dosing interval. | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
| Maebashi |
| Gunma |
| 371-8511 |
| Japan |
| Local Institution | Osaka | Osaka | 540-0006 | Japan |
| Local Institution | Sunto-Gun | Shizuoka | 411-8777 | Japan |
Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. |
| BG002 | Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. |
| OG002 | Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. |
|
|
| Secondary | Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. 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. Treatment-related=Possible, Probable, or Certain relationship to drug | All participants who received at least 1 dose of either ixabepilone or capecitabine. | Posted | Number | Participants | Baseline to Day 42, continuously |
|
|
|
| Secondary | Participant Tumor Response at Study Endpoint | Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which 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. | All treated participants with measurable disease and tumor response. | Posted | Number | Participants | At baseline and after every 42 days (every 2 21-day cycles) after baseline |
|
|
|
| Secondary | Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval | Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval. | All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
|
|
|
| Secondary | Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval | AUC = the average area under the concentration curve (AUC [INF]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours. | All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
|
|
|
| Secondary | Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval | T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval. | All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles. | Posted | Mean | Standard Deviation | Hours | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
|
|
|
| Secondary | Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval | Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval. | All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles. | Posted | Mean | Standard Deviation | Liters | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
|
|
|
| Secondary | Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval | CLT = total body clearance as determined from participant serum samples in one dosing interval. | All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles. | Posted | Mean | Standard Deviation | L/h | During Cycle 1 at specified timepoints (Day 1 to Day 8). |
|
|
|
| Primary | Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) | The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity. | All participants treated at the highest dose level. | Posted | Number | Participants | At the end of Cycle 2 (Day 42) |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. | 1 | 3 | 3 | 3 |
| EG002 | Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle. | 1 | 3 | 3 | 3 |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| MONOCYTE COUNT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| FLUSHING | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| PHLEBITIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| SEASONAL ALLERGY | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| NEURALGIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| CHEILITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| TONGUE PIGMENTATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| LYMPHANGITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| SKIN INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| PRURIGO | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| SKIN DISORDER | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| OROPHARYNGEAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| EXTRAVASATION | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| INJECTION SITE OEDEMA | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA 12.1 | 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.
| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Title | Measurements |
|---|---|
|
| Discontinued Due to AEs |
|
| SAEs |
|
| Related SAEs |
|
| Discontinued Due to SAEs |
|
| Deaths |
|
| Title | Measurements |
|---|---|
|
| PD |
|
| SD |
|