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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-0012 | 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) Sutent has on you and your prostate cancer.
The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, we believe that achieving a 30% freedom from clinical progression (PFS) (not including PSA progression) at 12 weeks represents biologically active therapy. Sunitinib malate (Sutent) represents a tolerable and convenient form of therapy with the potential for improving outcomes in AIPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib Malate | Experimental | Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | 50 mg/day orally each of Days 1-28 of each 6 week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival (PFS) Time at 1-year. | 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 last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overal Survival (OS) Rate at 1-year. | OS is measured from the date of randomization 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 last contact date. | 12 months |
| Prostate Specific Antigen (PSA) Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guru Sonpavde, MD | US Oncology Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Oncology Associates | Phoenix | Arizona | 85012 | United States | ||
| Connecticut Oncology & Hematology, LLP |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib Malate | Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline. |
| Baseline and up to 12 months |
| Change of PSA Doubling Time | Difference of PSA doubling time between baseline and end of the treatment. | Baseline and up to 12 months |
| Objective Response Rate (ORR) | ORR = Complete Response (CR) + Partial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. | 12 months |
| Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline. | Pain score decreased >=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week's average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week's period. | Baseline and up to 12 months |
| Torrington |
| Connecticut |
| 06790 |
| United States |
| Ocala Oncology Center | Ocala | Florida | 34474 | United States |
| Cancer Care & Hematology Specialista of Chicagoland | Niles | Illinois | 60714 | United States |
| Hope Center | Terre Haute | Indiana | 47802 | United States |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044 | United States |
| Alliance Hematology Oncology PA | Westminster | Maryland | 21157 | United States |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | United States |
| St. Joseph Oncology, Inc. | Saint Joseph | Missouri | 64507 | United States |
| Arch Medical Services, Inc. DBA The Cntr for Cancer Care & Research | St Louis | Missouri | 63141 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| NH Oncology-Hematology PA | Hooksett | New Hampshire | 03106 | United States |
| New Mexico Cancer Care Associates | Santa Fe | New Mexico | 87505 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Interlakes Oncology Hematology, PC | Rochester | New York | 14623 | United States |
| Cancer Centers of North Carolina | Raleigh | North Carolina | 27607 | United States |
| Greater Dayton Cancer Center | Kettering | Ohio | 45409 | United States |
| Medical Oncology Associates | Kingston | Pennsylvania | 18704 | United States |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Texas Cancer Center-Abilene(South) | Abilene | Texas | 79606 | United States |
| Texas Oncology, P.A.-Amarillo | Amarillo | Texas | 79106 | United States |
| Texas Cancer Center | Arlington | Texas | 76014 | United States |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | United States |
| Mamie McFaddin Ward Cancer Center | Beaumont | Texas | 77702 | United States |
| Texas Oncology, P.A.-Bedford | Bedford | Texas | 76022 | United States |
| Texas Cancer Center at Medical City | Dallas | Texas | 75230 | United States |
| Texas Onclogy, P.A. | Dallas | Texas | 75231 | United States |
| Methodist Charlton Cancer Ctr. | Dallas | Texas | 75237 | United States |
| Texas Oncology, P.A. | Dallas | Texas | 75246 | United States |
| Texas Cancer Center | Denton | Texas | 76210 | United States |
| El Paso Cancer Treatment Ctr | El Paso | Texas | 79915 | United States |
| Texas Oncology, P.A. | Fort Worth | Texas | 76104 | United States |
| Allison Cancer Center | Midland | Texas | 79701 | United States |
| Texas Oncology-Odessa | Odessa | Texas | 79761 | United States |
| Paris Regional Cancer Center | Paris | Texas | 75460 | United States |
| HOAST-Medical Dr. | San Antonio | Texas | 78229 | United States |
| Texas Oncology Cancer Center-Sugar Land | Sugar Land | Texas | 77479 | United States |
| Texas Oncology Cancer Care and Research | Waco | Texas | 76712 | United States |
| Texas Oncology, P.A. | Webster | Texas | 77598 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Onc and Hem Associates of SW VA, Inc. | Salem | Virginia | 24153 | United States |
| Puget Sound Cancer Center-Edmonds | Edmonds | Washington | 98026 | United States |
| Puget Sound Cancer Center-Seattle | Seattle | Washington | 98133 | United States |
| Northwest Cancer Specialists-Vancouver | Vancouver | Washington | 98684 | United States |
| Yakima Valley Mem Hosp/North Star Lodge | Yakima | Washington | 98902 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Total participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib Malate | Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Median Progression-free Survival (PFS) Time at 1-year. | 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 last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | ITT population | Posted | Median | Full Range | weeks | 12 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Overal Survival (OS) Rate at 1-year. | OS is measured from the date of randomization 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 last contact date. | ITT population | Posted | Number | 95% Confidence Interval | Probability of Survival at 1-year | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Prostate Specific Antigen (PSA) Response | Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline. | Evaluable population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and up to 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Change of PSA Doubling Time | Difference of PSA doubling time between baseline and end of the treatment. | Patients who had measurements of prior and post doubling time. | Posted | Median | Full Range | months | Baseline and up to 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR = Complete Response (CR) + Partial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. | Only patients with baseline measurable lesions. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline. | Pain score decreased >=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week's average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week's period. | Patients with pain measurement at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and up to 12 months |
|
|
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) (50 mg/day on Days 1-28 of 42-day cycles) | 7 | 35 | 29 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue 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 |
| |
| FAILURE KIDNEY ACUTE | Renal and urinary disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| NAUSEA AND VOMITING | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| STROKE | Vascular disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| THROMBOSIS PULMONARY | Respiratory, thoracic and mediastinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALKALINE PHOSPHASTASE SERUM INCREASE | Metabolism and nutrition disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| ANEMIA | Blood and lymphatic system 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 |
| |
| DIARRHEA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| DYSGUESIA | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| EDEMA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| HAND-FOOT SYNDROME | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| LEUCOPENIA | Blood and lymphatic system disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| MALAISE | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| MUCOSITIS | Gastrointestinal disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
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| 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 |
| |
| RASH | Skin and subcutaneous tissue disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal 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 |
| |
| WEIGHT LOSS | General disorders | COSTART, CTCAE v3.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guru Sonpavde | Texas Oncology Cancer Center | 2813327505 | Guru.Sonpavde@USOncology.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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