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The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in vitro and in vivo. The ultimate goal is to demonstrate the clinical activity of E7389 in the treatment of these, and potentially other, tumor types.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7389 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used. | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Schuster, Ph.D | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute Medical Group | Los Angeles | California | 90025 | United States | ||
| Premiere Oncology |
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This study was recruited at 2 centers in U.S.during the period of Aug 2003 to Apr 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | E7389 Dose-Escalating | E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | E7389 Dose-Escalating | E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used. | Posted | Number | participants | 12 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 | E7389 Dose-Escalating | E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | 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 | |
|---|---|---|---|---|
| Eisai Call Center | Eisai Inc | 888-422-4743 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C490954 | eribulin |
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| Santa Monica |
| California |
| 90404 |
| United States |
| New Brunswick | New Jersey | 08901 | United States |
| Physician Decision |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
| 10 |
| 21 |
| 20 |
| 21 |
| Diarrhea | Gastrointestinal disorders |
|
| Myocardial Infarction | Cardiac disorders |
|
| Hyponatremia | Investigations |
|
| Febrile Neutropenia | Blood and lymphatic system disorders |
|
| Pyrexia | General disorders |
|
| Infection | Infections and infestations |
|
| Headache | Nervous system disorders |
|
| Fatigue | General disorders |
|
| Metastases to Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonia | Infections and infestations |
|
| Bacteremia | Infections and infestations |
|
| Cellulitis | Infections and infestations |
|
| Dysphagia | Gastrointestinal disorders |
|
| Febrile Neutropenia | Blood and lymphatic system disorders |
|
| Leukopenia | Blood and lymphatic system disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders |
|
| Tachycardia | Cardiac disorders |
|
| Abdominal Distention | Gastrointestinal disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Abdominal Pain Upper | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Chest Pain | General disorders |
|
| Fatigue | General disorders |
|
| Mucosal Inflammation | General disorders |
|
| Peripheral Edema | General disorders |
|
| Pyrexia | General disorders |
|
| Oral Candidiasis | Infections and infestations |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Alanine Aminotransferase Increased | Investigations |
|
| Blood Alkaline Phosphatase Increased | Investigations |
|
| Weight Decreased | Investigations |
|
| White Blood Cell Count Decreased | Investigations |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Decreased Appetite | Metabolism and nutrition disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Hyponatremia | Metabolism and nutrition disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Chest Wall Pain | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Insomnia | Psychiatric disorders |
|
| Dysuria | Renal and urinary disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnea Exertional | Respiratory, thoracic and mediastinal disorders |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Dry Skin | Skin and subcutaneous tissue disorders |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders |
|
| Night Sweats | Skin and subcutaneous tissue disorders |
|
| Pruritis | Skin and subcutaneous tissue disorders |
|
| Rash Pruritic | Skin and subcutaneous tissue disorders |
|
| Hypotension | Vascular disorders |
|
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