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This study has closed to accrual early due to slow accrual.
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Bayer | INDUSTRY |
| Breast Cancer Research Foundation | OTHER |
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The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZK219477 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZK219477 | Drug | Given intravenously over approximately 30 minutes once every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate in the Central Nervous System (CNS) | Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (Any Grade) | Adverse events per NCI CTCAE | 2 years |
| Objective Response Rate in Non-Central Nervous System (CNS) Sites | Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Lin, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
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Patients were enrolled at Dana-Farber/Harvard Cancer Center between 8/1/2007-10/29/2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sagopilone | Either 16 mg/m2 or 22 mg/m2 IV Q3W |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sagopilone | Either 16 mg/m2 or 22 mg/m2 IV Q3W |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate in the Central Nervous System (CNS) | Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline. | The study was closed prior to full accrual as detailed in the manuscript | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
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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 | Sagopilone | Either 16 mg/m2 or 22 mg/m2 IV Q3W |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nancy Lin | Dana-Farber Cancer Institute | 617-632-2335 | nlin@partners.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002493 | Central Nervous System Diseases |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C530494 | sagopilone |
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| 2 years |
| Time to Progression at Any Site. | Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0 | 2 years |
| Clinical Benefit Rate. | CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease | 2 years |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Subjects With Adverse Events (Any Grade) | Adverse events per NCI CTCAE | Study was closed prior to full accrual for reasons detailed in published manuscript | Posted | Number | participants | 2 years |
|
|
|
| Secondary | Objective Response Rate in Non-Central Nervous System (CNS) Sites | Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease | only included the 8 pts with measurable non-CNS disease at baseline. The 7 pts with non-measurable non-CNS disease at baseline were not included in the denominator for this endpoint | Posted | Number | percentage of participants | 2 years |
|
|
|
| Secondary | Time to Progression at Any Site. | Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0 | all patients who received at least 1 dose of protocol therapy | Posted | Median | Full Range | months | 2 years |
|
|
|
| Secondary | Clinical Benefit Rate. | CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease | all pts who received at least 1 dose of protocol therapy | Posted | Number | percentage of participants | 2 years |
|
|
|
| 1 |
| 15 |
| 15 |
| 15 |
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Neurologic-other | Nervous system disorders | Systematic Assessment |
|
| Neuropathy-Sensory | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Blurred/Double Vision | Nervous system disorders | Systematic Assessment |
|
| Eye Pain/ Headache | Nervous system disorders | Systematic Assessment |
|
| Ataxia | Nervous system disorders | Systematic Assessment |
|
| Muscle/Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Limb Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Generalized Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Bicarbonate | Metabolism and nutrition disorders | Systematic Assessment |
|
| Liver Function Tests | Hepatobiliary disorders | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Mucositis | Infections and infestations | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymphocytes | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neuropathy-Motor | Nervous system disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D009422 | Nervous System Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |