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| ID | Type | Description | Link |
|---|---|---|---|
| GA6181UU | Other Identifier | Pfizer |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.
In this trial, the activity and tolerability of sunitinib malate (Sutent) will be examined in previously untreated elderly patients (>70 years old) felt not to be candidates for standard cytotoxic chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib Malate | Experimental | Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sutent | Drug | Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Disease control rate = CR + PR + SD>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. | Every 6 weeks until progressive disease or death due to any cause, up to 36 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rates (OR) | Overall response rates = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Every 6 weeks until progressive disease or death due to any causes, up to 36 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig H. Reynolds, MD | US Oncology Research, LLC; Ocala Oncology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocala Oncology Center | Ocala | Florida | 34471 | United States | ||
| Cancer Centers of Florida, P.A. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib Malate | Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib Malate | Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-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 | Disease Control Rate (DCR) | Disease control rate = CR + PR + SD>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. | Evaluable population | Posted | Number | 95% Confidence Interval | percentage of participants | Every 6 weeks until progressive disease or death due to any cause, up to 36 month. |
|
During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
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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 | Sunitinib Malate | Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Reynolds | Ocala Oncology, Ocala, FL, USA | 352-732-4032 | Craig.Reynolds@USOncology.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Progression-free Survival (PFS) | PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | All patients were followed until progressive disease or death, up to 36 months. |
| 1-year Overall Survival (OS) Rate. | OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact. | All patients were followed until death or up to 36 months. |
| Time to Progression (TTP) | TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | All patients were followed until progressive disease or death, up to 36 months. |
| Ocoee |
| Florida |
| 34761 |
| United States |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | United States |
| Cancer Centers of North Carolina | Raleigh | North Carolina | 27607 | United States |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401-8122 | United States |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Texas Oncology - Arlington South | Arlington | Texas | 76014 | United States |
| Texas Oncology, P.A. - Bedford | Bedford | Texas | 76022 | United States |
| Methodist Charlton Cancer Ctr. | Dallas | Texas | 75237 | United States |
| Texas Cancer Center of Mesquite | Mesquite | Texas | 75150 | United States |
| Texas Oncology Cancer Care and Research Center | Waco | Texas | 76712 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Yakima Valley Mem Hosp/North Star Lodge | Yakima | Washington | 98902 | United States |
| Adverse Event |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Response Rates (OR) | Overall response rates = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Evaluable population | Posted | Number | 95% Confidence Interval | percentage of participants | Every 6 weeks until progressive disease or death due to any causes, up to 36 months. |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | ITT population | Posted | Median | Full Range | months | All patients were followed until progressive disease or death, up to 36 months. |
|
|
|
| Secondary | 1-year Overall Survival (OS) Rate. | OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants alive at 1yr | All patients were followed until death or up to 36 months. |
|
|
|
| Secondary | Time to Progression (TTP) | TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | ITT population | Posted | Median | Full Range | months | All patients were followed until progressive disease or death, up to 36 months. |
|
|
|
| 11 |
| 60 |
| 45 |
| 60 |
| ANEMIA HEMOLYTIC (NOS) | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| APPETITE DECREASED | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| BLEEDING GASTROINTESTINAL | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| COLITIS ULCERATIVE | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DEHYDRATION | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| FATIGUE | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HEMORRHAGE (NOS) | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| JAUNDICE | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| MUCOSITIS ORAL | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PAIN HEAD | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| ANOREXIA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DEHYDRATION | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| DYSGUESIA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| FATIGUE | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| GASTROESOPHAGEAL REFLUX | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| HEADACHE | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| INFECTION FUNGAL | Infections and infestations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| INSOMNIA | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| MUCOSITIS | Infections and infestations | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| NEUROPATHY | Nervous system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PAIN MOUTH | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| PROTEINURIA | Renal and urinary disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| WEAKNESS | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| WEIGHT LOSS | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |