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| ID | Type | Description | Link |
|---|---|---|---|
| E7389 | |||
| BOLD |
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To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E7389 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7389 | Drug | E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the Maximum Tolerated Dose | 28 Days |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dale Shuster, Ph.D. | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Bronx | New York | 10461 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | E7389 | E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | E7389 | E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Determination of the Maximum Tolerated Dose | Posted | Number | mg/m^2 | 28 Days |
|
|
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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 | E7389 | E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Tarassoff | Eisai Inc. | 888-422--4743 |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C490954 | eribulin |
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| San Antonio |
| Texas |
| United States |
| Discon Therapy |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Please note: 8 subjects in unknown category were Hispanic/Latino | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 12 |
| 32 |
| 32 |
| 32 |
| Chest Pain | General disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
|
| Klebsiella Infection | Infections and infestations |
|
| Renal Insufficiency | Renal and urinary disorders |
|
| Pain | General disorders |
|
| Fatigue | General disorders |
|
| Spinal Cord Compression | Nervous system disorders |
|
| Paraparesis | Nervous system disorders |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Anoxic Encephalopathy | Nervous system disorders |
|
| Multi-Organ System Failure | General disorders |
|
| Sepsis | Infections and infestations |
|
| Nausea | Gastrointestinal disorders |
|
| Febrile Neutropenia | Blood and lymphatic system disorders |
|
| Anemia | Blood and lymphatic system disorders |
|
| Catheter Related Infection | Infections and infestations |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Intestinal Obstruction | Gastrointestinal disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Palpitations | Cardiac disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Abdominal Pain Lower | Gastrointestinal disorders |
|
| Ascites | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Chest Pain | General disorders |
|
| Fatigue | General disorders |
|
| Peripheral Edema | General disorders |
|
| Pain | General disorders |
|
| Pyrexia | General disorders |
|
| Aspartate Aminotransferase Increased | Investigations |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Hypomagnesemia | Metabolism and nutrition disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Muscle Cramp | Musculoskeletal and connective tissue disorders |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Hypoaesthesia | Nervous system disorders |
|
| Neuropathy | Nervous system disorders |
|
| Paraesthesia | Nervous system disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Pharyngeal Erythema | Respiratory, thoracic and mediastinal disorders |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders |
|
| Pruritis | Skin and subcutaneous tissue disorders |
|
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