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Unable to determine the optimum tolerated dose
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The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor support with G-CSF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: 80 mg ABI-007 + 15 mg vinorelbine | Experimental | Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned. |
|
| Part 2: 80 mg ABI-007 + 15 mg vinorelbine | Experimental | Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
| Part 2: 90 mg ABI-007 + 20 mg vinorelbine | Experimental | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-007 | Drug | Weekly intravenous infusions over 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) | Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. | up to month 30 |
| Participants With Dose Limiting Toxicities | Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Any drug-related toxicities CTC Grade 3 or higher were considered dose limiting. Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death. Other conditions considered dose-limiting toxicities include:
The optimal tolerated dose of ABI-007 and vinorelbine given concurrently was defined as the dose administered in the absence of DLTs. | up to month 1 |
| Percentage of Participants With Discontinued, Delayed or Interrupted Therapy | Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events. | up to week 129 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) | Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions. |
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Inclusion Criteria:
Patient has microscopically confirmed invasive breast carcinoma with clinical and/or radiographic evidence of stage 4 disease. If diagnosis is based on pleural effusion, positive cytology must be confirmed.
Patient has had no prior chemotherapy for Stage 4 disease (hormone therapy is permitted). Prior adjuvant paclitaxel by 3-hour infusion is permitted, if there is no residual neuropathy. Prior adjuvant docetaxel on an every 3 week schedule is permitted.
Disease must be measurable (unidimensional by Response Evaluation Criteria In Solid Tumors (RECIST) criteria) or evaluable (e.g., malignant effusion, marrow involvement). Elevated tumor markers alone are insufficient.
Age >18.
Southwest Oncology Group (SWOG)/Eastern Oncology Group (ECOG) performance status must be < or =2 at screen and on treatment day one.
Life expectancy must be estimated at >16 weeks.
Prior irradiation is permitted, provided:
Informed consent must be obtained prior to registration.
Patients must be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin C or nitrosureas), or > 2 weeks from prior hormonal therapy.
All patients must have placement of appropriate central venous access device.
Tumor HER2/neu expression must be determined prior to study enrollment. Assessment may be by fluorescence in situ hybridization (FISH) assay or by immunohistochemistry (ICC). If determination is intermediate by ICC, FISH must be performed. For enrollment purposes, this phase I study will not discriminate based on HER2 status. However, documentation of patients' HER2 status will be maintained and Herceptin will be prescribed for all HER2 positive patients.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Care Center | Duarte | California | 91010 | United States | ||
| Seattle Cancer Care Alliance |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: 80 mg ABI-007 + 15 mg Vinorelbine | Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| vinorelbine | Drug | Weekly intravenous infusions over 10-30 minutes, immediately after ABI-007. Vinorelbine is commercially available and was not supplied by the Sponsor. |
|
|
| Trastuzumab | Drug | Trastuzumab was administered to participants who had HER-2-neu positive tumors. Participants received trastuzumab by IV infusion via a vascular access device following dosing with ABI-007 and vinorelbine. During their first cycle, 4 mg/kg was administered on day 1 of that cycle as a loading dose. During subsequent weekly treatments, 2 mg/kg was administered. Trastuzumab is commercially available and was not supplied by the Sponsor. |
|
|
| G-CSF | Biological | During Part 1, participants followed a dosing regimen with ABI-007 and vinorelbine without G-CSF treatment. However, G-CSF was allowed for administration as necessary in accordance with commonly accepted clinical guidelines. In Part 2, participants started G-CSF treatment in concurrence with their ABI-007 and vinorelbine treatments. G-CSF was administered to all participants on Days 2-7 of each cycle, at a dose of 5 mcg/kg. If the participant's absolute neutrophil (ANC) count was >20,000/mm^3 on the day of anticipated chemotherapy, the site staff reduced the daily dose of G-CSF by 50% to 2.5 mcg/kg. G-CSF is commercially available and was not supplied by the Sponsor. |
|
|
| Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3) | Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) blood counts were graded using NCI CTCAE version 3. ANC: Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 1.5*10^9/L; Grade 2 = <1.5 - 1.0*10^9/L; Grade 3 = <1.0 - 0.5*10^9/L; Grade 4 = <0.5*10^9/L WBC: Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L Platelets: Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L Hemoglobin: Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100 g/L ; Grade 2 = <100 - 80 g/L; Grade 3 = <80 - 65 g/L; Grade 4 = <65 g/L | up to week 129 (longest treatment) |
| Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count | Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment. | up to week 129 (longest treatment) |
| Nadir Measurement for Hemoglobin (Hgb) | Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment. | up to week 129 (longest treatment) |
| up to month 30 |
| Kaplan Meier Estimate for Time to Disease Progression (TTP) | Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. | up to month 30 |
| Kaplan-Meier Estimate for Duration of Response | Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) are defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. | up to month 30 |
| Kaplan Meier Estimate for Progression-Free Survival (PFS) | PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Because no patients died as a result of a non-disease progression event, the analysis of PFS was identical to the analysis for TTP. | up to month 30 |
| Kaplan-Meier Estimates for Participant Survival | Participant survival is the time from the first dose of study drug to participant death from any cause. Participants that did not die were censored at the last known time the participant was alive. | up to 39 months |
| Seattle |
| Washington |
| 98109 |
| United States |
| FG001 | Part 2: 80 mg ABI-007 + 15 mg Vinorelbine | Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
| FG002 | Part 2: 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: 80 mg ABI-007 + 15 mg Vinorelbine | Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned. |
| BG001 | Part 2: 80 mg ABI-007 + 15 mg Vinorelbine | Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
| BG002 | Part 2: 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
| 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, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Menopausal Status | Number | participants |
| ||||||||||||||||
| Smoking Status | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Number | 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 With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) | Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. | Treated population | Posted | Number | 95% Confidence Interval | percentage of participants | up to month 30 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Participants With Dose Limiting Toxicities | Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Any drug-related toxicities CTC Grade 3 or higher were considered dose limiting. Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death. Other conditions considered dose-limiting toxicities include:
The optimal tolerated dose of ABI-007 and vinorelbine given concurrently was defined as the dose administered in the absence of DLTs. | Treated population | Posted | Number | participants | up to month 1 |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Discontinued, Delayed or Interrupted Therapy | Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events. | Treated population | Posted | Number | percentage of participants | up to week 129 |
| ||||||||||||||||||||||||||||||||||
| Primary | Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3) | Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) blood counts were graded using NCI CTCAE version 3. ANC: Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 1.5*10^9/L; Grade 2 = <1.5 - 1.0*10^9/L; Grade 3 = <1.0 - 0.5*10^9/L; Grade 4 = <0.5*10^9/L WBC: Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L Platelets: Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L Hemoglobin: Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100 g/L ; Grade 2 = <100 - 80 g/L; Grade 3 = <80 - 65 g/L; Grade 4 = <65 g/L | Treated population | Posted | Number | participants | up to week 129 (longest treatment) |
| ||||||||||||||||||||||||||||||||||
| Primary | Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count | Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment. | Treated population | Posted | Mean | Standard Deviation | 10^9/L | up to week 129 (longest treatment) |
| |||||||||||||||||||||||||||||||||
| Primary | Nadir Measurement for Hemoglobin (Hgb) | Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment. | Treated population | Posted | Mean | Standard Deviation | g/L | up to week 129 (longest treatment) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) | Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions. | Treated population | Posted | Number | percentage of participants | up to month 30 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate for Time to Disease Progression (TTP) | Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. | Treated population of participants with disease progression | Posted | Median | 95% Confidence Interval | months | up to month 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate for Duration of Response | Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) are defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. | Treated participants who had a response | Posted | Median | 95% Confidence Interval | months | up to month 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate for Progression-Free Survival (PFS) | PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Because no patients died as a result of a non-disease progression event, the analysis of PFS was identical to the analysis for TTP. | Treated population of participants who had disease progression or who died | Posted | Median | 95% Confidence Interval | months | up to month 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimates for Participant Survival | Participant survival is the time from the first dose of study drug to participant death from any cause. Participants that did not die were censored at the last known time the participant was alive. | Treated population | Posted | Median | 95% Confidence Interval | months | up to 39 months |
|
Day 1 - up to 133 weeks (longest treatment plus 4 weeks)
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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 | 80 mg ABI-007 + 15 mg Vinorelbine | Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants from study Parts 1 and 2 are combined. | 5 | 10 | 10 | 10 | ||
| EG001 | 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants are from study Part 2. | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Keratoconjunctivitis sicca | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Post procedural nausea | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Catheter site rash | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Gait abnormal | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Oedema mucosal | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rigors | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Blister | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| Hepatic trauma | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| Alanine aminotransferase | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Haematocrit | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Iron binding capacity total decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Facial pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
|
Celgene shall complete its review within 30 days after receipt of a proposed publication or presentation submitted by the investigator. Upon request, the publication/presentation might be delayed up to 60 additional days for Celgene to secure intellectual property protection. Subsequent to the multicenter publication or one year after study completion, whichever occurs first, an investigator and/or his/her colleagues may publish the results of INVESTIGATOR's part of the study independently.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D000077235 | Vinorelbine |
| D000068878 | Trastuzumab |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
Not provided
Not provided
| >= 65 years |
|
| Male |
|
| White, Non-Hispanic and Non-Latino |
|
| White, Hispanic or Latino |
|
| Post-menopausal |
|
| Current Smoker |
|
| Previous Smoker, but have Stopped |
|
| Status 1 (Symptomatic but completely ambulatory) |
|
| Status 2 (Ambulatory but unable to work) |
|
| Status 3 (Limited self-care) |
|
| Status 4 (Completely disabled) |
|
| Status 5 (Death) |
|
| OG002 | Part 2: 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
|
|
|
| OG001 |
| Part 2: 80 mg ABI-007 + 15 mg Vinorelbine |
Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
| OG002 | Part 2: 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
|
Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
|
Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
|
|
| OG002 | Part 2: 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
|
| OG002 | Part 2: 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
|
Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
| OG002 | Part 2: 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
|
| OG002 | Part 2: 90 mg ABI-007 + 20 mg Vinorelbine | Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given. |
|
|
Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
|
|