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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Aventis Pharmaceuticals | INDUSTRY |
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This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib | Drug | Imatinib |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | 18 months |
| Overall Survival (OS) |
Not provided
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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| Name | Affiliation | Role |
|---|---|---|
| Denise A. Yardley, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States | ||
| Consultants in Blood Disorders and Cancer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19933079 | Result | Yardley DA, Burris HA 3rd, Markus T, Spigel DR, Greco FA, Mainwaring M, Waterhouse DM, Webb CD, Hainsworth JD. Phase II trial of docetaxal plus imatinib mesylate in the treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4):237-42. doi: 10.3816/CBC.2009.n.040. |
| Label | URL |
|---|---|
| Published article in Clinical Breast Cancer | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 (ORR) | Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months |
|
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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 | Docetaxel+Imatinib | Patients received docetaxel 30mg/m2 IV weekly on days 1, 8, and 15 of each 28 day cycle. Patients received oral imatinib 400mg daily. Fifteen patients initially received oral imatinib 600mg daily but had their dose reduced to 400mg daily when they were unable to tolerate the higher dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection - carcinomatous meningitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D. Hainsworth, MD | Sarah Cannon Research Institute | 877-691-7274 | ASKSARAH@scresearch.net |
Not provided
| 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 |
|---|---|
| D000068877 | Imatinib Mesylate |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Docetaxel |
| Drug |
Docetaxel |
|
|
Defined as the time from first protocol treatment to date of death due to any cause. |
| 18 months |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| Baton Rouge General Medical Center | Baton Rouge | Louisiana | 70806 | United States |
| Methodist Cancer Center | Omaha | Nebraska | 68114 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Progression Free Survival (PFS) | PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Posted | Median | 95% Confidence Interval | Months | 18 months |
|
|
|
| Secondary | Overall Survival (OS) | Defined as the time from first protocol treatment to date of death due to any cause. | Posted | Median | 95% Confidence Interval | months | 18 months |
|
|
|
| 18 |
| 37 |
| 37 |
| 37 |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (diverticular abscess) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - abdomen | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - chest | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - pleura | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac ischemia/infarction - rheumatic heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Spinal cord compression | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/embolism (vascular access) | Vascular disorders | CTCAE (3.0) | Systematic Assessment | Deep vein thrombosis |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT, SGPT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Altered mental status | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST, SGOT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Disease progression (carcinomatous meningitis) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Chills | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema - periorbital | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperlacrimation | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - herpes zoster | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - thrush | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - urinary tract | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphedema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myalgia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Night sweats | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - abdomen | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - chest | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - joint | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - throat | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastroesophageal reflux disorder | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste alteration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombus/thrombosis/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic reaction | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| D017437 |
| Skin and Connective Tissue Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |