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This is a Phase 1 study during which patients with advanced cancer will receive investigational study drug ARRY-382. Patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-382 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-382, cFMS inhibitor; oral | Drug | multiple dose, escalating |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms. | Safety will be characterized for the duration of time that each patient stays on study; estimated one year. | |
| Establish the maximum tolerated dose (MTD) of study drug. | The MTD will be based on Cycle 1 (28 days). | |
| Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites. | Safety will be characterized for the duration of time that each patient stays on study; estimated one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of study drug in terms of incidence of response rate and duration of response. | All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States | ||
| South Texas Accelerated Research Therapeutics (START) |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| San Antonio |
| Texas |
| 78229 |
| United States |