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| Name | Class |
|---|---|
| Synta Pharmaceuticals Corp. | INDUSTRY |
The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the patient and their breast cancer.
STA-9090 is an experimental drug that works by breaking down cancer proteins. When the cancer proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that is not yet approved for the treatment of cancer by the United States (FDA) Food and Drug Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose for this drug has been found. We are now interested to see how active this drug is against breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STA-9090 | Experimental | This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STA-9090 | Drug | All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response | Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shanu Modi, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan-Kettering Cancer Center at Commack |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | STA-9090 | This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer. STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | STA-9090 | This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer. STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression. |
| 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 | Overall Response Rate | To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response | Posted | Number | participants | Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle |
|
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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 | STA-9090 | This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer. STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac General, other | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Investigations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Modi, Shanu/Medicine (Assistant Attending) | Memorial Sloan Kettering Cancer Center | +1646-888-4564 | modis@mskcc.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C533237 | STA 9090 |
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| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York | 10591 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 6 |
| 22 |
| 20 |
| 22 |
| Death not assoc w CTCAE term- Death NOS | General disorders |
|
| Death not assoc w CTCAE term-Disease prog NOS | General disorders |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders |
|
| Liver dysfunction/failure | Hepatobiliary disorders |
|
| Pain - Abdomen NOS | Gastrointestinal disorders |
|
| Pleural effusion (non-malig) | Respiratory, thoracic and mediastinal disorders |
|
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders |
|
| AST, SGOT | Investigations |
|
| Alkaline phosphatase | Investigations |
|
| Amylase | Investigations |
|
| Bilirubin (hyperbilirubinemia) | Investigations |
|
| CPK (creatine phosphokinase) | Investigations |
|
| Creatinine | Investigations |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders |
|
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders |
|
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders |
|
| Hemoglobin | Investigations |
|
| Hypertension | Vascular disorders |
|
| INR | Investigations |
|
| Insomnia | Psychiatric disorders |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders |
|
| Lipase | Investigations |
|
| Lymphopenia | Investigations |
|
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations |
|
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders |
|
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders |
|
| Platelets | Investigations |
|
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders |
|
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders |
|
| Weight loss | Investigations |
|
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| D017437 |
| Skin and Connective Tissue Diseases |