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This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-334543 + docetaxel + prophylactic growth factors | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-334543, EGFR/ErbB2 inhibitor; oral | Drug | multiple dose, escalating |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish the maximum tolerated dose (MTD) of study drug in combination with docetaxel. | Duration of study | |
| Characterize the safety profile of study drug in combination with docetaxel in terms of adverse events, clinical laboratory tests and electrocardiograms. | Duration of study | |
| Characterize the pharmacokinetics (PK) of study drug and docetaxel. | Duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of the study drug in combination with docetaxel in terms of tumor response. | Duration of study |
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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 |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States | ||
| Mayo Cancer Center |
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| Docetaxel, mitotic inhibitor; intravenous | Drug | multiple dose, single schedule |
|
| Prophylactic growth factors; subcutaneous | Drug | standard of care |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| C000595244 | ARRY-334543 |
| D000077143 | Docetaxel |
| D050256 | Antimitotic Agents |
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D050258 | Mitosis Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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