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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00299 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The goal of this clinical research study is to learn if dovitinib can help to control inflammatory breast cancer. The safety of this drug will also be studied.
The Study Drug:
Dovitinib is designed bind to a protein on the surface of cancer cells called the FGF receptor. This may slow the growth of cancer cells or kill cancer cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take dovitinib by mouth each day for 5 days and have a 2-day rest period (5 days on/2 days off schedule). The first dose of each week is Day 1. You should take dovitinib in the morning with a glass (about 8 ounces) of water at least 1 hour before or at least 2 hours after eating. It is important that you take the study drug at about the same time every day.
If you forget to take a dose of the study drug as scheduled, or take a dose during your 2-day rest period, you should follow the guidelines below or call your study staff:
You should not take additional medications including over-the-counter products and herbal/alternative medications during the study without asking your doctor. It is important to avoid medications that are known to cause liver side effects.
If you experience intolerable side effects, the study doctor may give you drugs to help control the side effects.
You should store the study drug at room temperature and out of direct sunlight. The study drug should also be kept away from children.
About every 4 weeks, you will need to bring back your empty or partially used bottles of study drug.
During Treatment:
At every visit, you will be asked if you have had any side effects.
Before each Cycle:
Cycle 1, around Days 8 and 22:
° Blood (about 1 tablespoon) will be drawn to check your liver function.
Cycle 2 around Day 8:
° Blood (about 1 tablespoon) will be drawn to check your liver function.
Every 2 cycles (before Cycles 3, 5, 7, and so on):
Before Cycle 3:
You will also have a one-time blood draw (about 1 tablespoon) to measure the level of the study drug in your blood. This sample may be drawn on Days 12 or 26 of Cycle 1, before Cycle 2, or on Day 12 of Cycle 2.
If the doctor thinks it is needed, any of these tests and procedures may be performed earlier. If the doctor thinks it is needed, you will have an ECG, ECHO, or MUGA scan to check your heart function.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study treatment if the disease gets worse or you experience intolerable side effects.
Your participation on the study will be over once you have completed the end-of-treatment visit.
End-of-Treatment Visit:
After you are off study, you will have a end-of-treatment visit within 14 days after the last study visit.
Follow-up Visits:
You will be called or e-mailed every 3 months for up to 1 year and asked how you are doing.
This is an investigational study. Dovitinib is not FDA approved or commercially available. At this time, dovitinib is only being used in research.
Up to 33 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dovitinib | Experimental | A complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days). Patients receive a single daily oral dose of 500 mg of dovitinib for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dovitinib | Drug | 500 mg by mouth for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants | Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs) | Safety analysis evaluated by grading each adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and reporting the type, frequency and severity in a summary format. Full AE reporting can be found in the Adverse Event Section. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicente Valero, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: January 27, 2012 to July 29, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dovitinib | Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dovitinib | Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 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 | 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 (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants | Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid | Three participants were not evaluable for response due to early departure from study. | Posted | Number | participants | 6 months |
|
Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
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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 | Dovitinib | Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicente Valero, MD/Professor, Breast Medical Oncology | The University of Texas (UT) MD Anderson Cancer Center | 713-792-7734 | vvalero@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2013 | Jun 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D058922 | Inflammatory Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C500007 | 4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG000 | Dovitinib | Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle. |
|
|
| Secondary | Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs) | Safety analysis evaluated by grading each adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and reporting the type, frequency and severity in a summary format. Full AE reporting can be found in the Adverse Event Section. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| 20 |
| 22 |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Chest wall pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ejection fraction decreased | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Sinus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified - Disease Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Oral pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |