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The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg | Experimental |
| |
| Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg | Experimental |
| |
| Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg | Drug | Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study | CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions. | Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression |
| Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart. | Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression-free Survival at Week 24 | Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24. Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months. | Date of randomization to Week 24 |
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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 |
|---|---|---|---|---|---|---|
| East Valley Hematology And Oncology Medical Group | Burbank | California | 91505 | United States | ||
| Wilshire Oncology Medical Group, Inc. |
Of the 136 participants enrolled in this study, 123 were randomized. Of the 13 not randomized, 11 no longer met study criteria, 1 withdrew, and 1 was found to have extensive disease. Of the 123 randomized, 122 were treated, and 1 no longer met study criteria and was never treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg | Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg | Drug | Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity (After Cycle 4, dose reduction to 32 mg/m^2 was to be implemented for all subsequent cycles.) Bevacizumab, 15 mg/kg, administered as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Drug | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| Median Progression-free Survival (PFS) | PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression. Participants who did not progress or die were to be censored on the date of their last tumor assessment. | Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months) |
| Median Time to Response | Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first. Time to response was computed only for participants whose best response was PR or CR. | Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks) |
| Median Duration of Response | Duration of response was computed for participants whose best response was either PR or CR. Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death. Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment. | Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks) |
| Percentage of Participants Surviving at 1 Year | One year survival rates were computed using Kaplan-Meier estimates. | Date first participant enrolled to 1 year |
| Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs | An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. | At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug |
| Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | CTC, Version 3 used to assess parameters. CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count. LLN=lower level of normal. WBC Gr 1:\ | At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle |
| Number of Participants With Abnormalities in Liver Function by Worst CTC Grade | ULN=Upper limit of normal.ALT 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; ALP 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. | At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle |
| Number of Participants With Abnormalities in Renal Function by Worst CTC Grade | Creatine Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN. | At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle |
| La Verne |
| California |
| 91750 |
| United States |
| Ucsf-Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | United States |
| Ellis Fischel Cancer Center | Columbia | Missouri | 65203 | United States |
| Weill Medical College Of Cornell University | New York | New York | 10021 | United States |
| Local Institution | Besançon | 25030 | France |
| Local Institution | Clermont-Ferrand | 63000 | France |
| Local Institution | Marseille | 13273 | France |
| Local Institution | Paris | 75475 | France |
| Local Institution | Saint-Herblain | 44805 | France |
| Local Institution | Strasbourg | 67085 | France |
| Local Institution | Tours | 37044 | France |
| Local Institution | Cuneo | 12100 | Italy |
| Local Institution | Meldola Fc | 47014 | Italy |
| Local Institution | Milan | 20132 | Italy |
| Local Institution | Modena | 41100 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Roma | 00161 | Italy |
| Local Institution | Jaén | 23007 | Spain |
| Local Institution | L'Hospitalet de Llobregat | 08907 | Spain |
| Local Institution | Chelmsford | Essex | CM1 7ET | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| Local Institution | Merseyside | Merseyside | CH63 4JY | United Kingdom |
| Local Institution | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| FG001 | Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg | Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| FG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg | Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| BG001 | Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg | Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| BG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study | CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Progression-free Survival at Week 24 | Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24. Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Date of randomization to Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Median Progression-free Survival (PFS) | PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression. Participants who did not progress or die were to be censored on the date of their last tumor assessment. | All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Median Time to Response | Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first. Time to response was computed only for participants whose best response was PR or CR. | Participants whose best response was CR or PR, as assessed by the investigator. | Posted | Median | Full Range | Weeks | Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Median Duration of Response | Duration of response was computed for participants whose best response was either PR or CR. Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death. Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment. | Participants whose best response was CR or PR, as assessed by the investigator. | Posted | Median | 95% Confidence Interval | Months | Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Surviving at 1 Year | One year survival rates were computed using Kaplan-Meier estimates. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Date first participant enrolled to 1 year |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs | An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. | All randomized participants who received any study drug. | Posted | Number | Participants | At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart. | All randomized participants | Posted | Number | Participants | Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | CTC, Version 3 used to assess parameters. CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count. LLN=lower level of normal. WBC Gr 1:\ | All randomized participants who received any study drug. | Posted | Number | Participants | At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Liver Function by Worst CTC Grade | ULN=Upper limit of normal.ALT 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; ALP 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. | All randomized participants who received any study drug and had samples available. | Posted | Number | Participants | At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Renal Function by Worst CTC Grade | Creatine Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN. | All randomized participants who received any study drug and had samples available. | Posted | Number | Participants | At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle |
|
Continuously from first to last dose of study drug (24 weeks)and within 30 days following 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 | Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg | Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone, as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. | 15 | 45 | 45 | 45 | ||
| EG001 | Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg | Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity. After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone, as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. | 16 | 45 | 45 | 45 | ||
| EG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. | 9 | 32 | 32 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatinine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Complicated migraine | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Bacteroides infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Leukopenia | 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 |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Sciatica | 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 |
| |
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | 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 |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rash | 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 |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Mucosal inflammation | 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 of 60 days or less 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C430592 | ixabepilone |
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| C089957 | BMS 181339 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg |
Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg |
Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|
| OG002 | Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. |
|
|