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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-0575 | Other Identifier | Institutional Review Board | |
| NCI-2012-00142 | Registry Identifier | NCI Trial ID | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The main purpose of this study is to learn more about the safety of an investigational drug, axitinib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. Researchers will also see what changes happen to the tumors while taking the axitinib and after it is stopped (during the scheduled breaks), and what changes in the tumor may be responsible for this growth. This will be done by using a special kind of scan called an 18F-FLT PET/CT. This scan is considered an investigational type of scan and is not used for clinical care. These scans are not approved by the FDA, their use in this study is just for research purposes.
In addition, the investigators want to find out how the drug is processed and distributed in the human body. The investigators will also look at how different types of cancer are affected by axitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety cohort | Experimental | 6 evaluable patients with RECIST measurable solid malignancies will be enrolled to establish the safety and toxicity of axitinib at 7 mg PO BID days 1-14 in 21 day cycles. |
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| Pharmacodynamic cohort | Experimental | PD cohort A: Up to 6 patients with metastatic castrate-resistant prostate cancer (evidence of soft-tissue metastases amendable to FLT-PET/CT imaging), and PD cohort B: Up to 12 patients with other solid malignancies (evidence of radiographic metastases amendable to FLT-PET/CT imaging) will be enrolled with scans obtained at baseline, peak exposure, and peak withdrawal of axitinib, in cycle#1, with repeat imaging in select patients in PD cohorts A and B at a later cycle of therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| axitinib | Drug | 7 mg PO BID days 1-14 in 21 day cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic change on FLT-PET/CT | baseline, cycle 1 weeks 2 and 3, pre-cycle 3, cycle 3 weeks 2 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Liu, M.D. | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| ID | Term |
|---|---|
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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