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This is a Phase 1 study during which patients with advanced solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-334543 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-334543, EGFR/ErbB2 inhibitor; oral | Drug | single dose and multiple dose, escalating |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety profile of the new formulation of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. | Duration of study | |
| Establish the maximum tolerated dose (MTD) of the new formulation of study drug. | Duration of study | |
| Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state. | Day 1 and Day 8 | |
| Assess the exposure of the new formulation of study drug in terms of plasma concentrations. | Duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment. | Duration of study |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Center at Hamilton Heath Sciences | Hamilton | Ontario | L8V 5C2 | Canada | ||
| Ottawa Hospital Cancer Centre |
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| ID | Term |
|---|---|
| C000595244 | ARRY-334543 |
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| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |