Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-334543 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-334543, EGFR/ErbB2 inhibitor; oral | Drug | Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish the maximum tolerated dose (MTD) of study drug. | Part 1 | |
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. | Part 1 and Part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations. | Part 1 and Part 2 | |
| Assess the efficacy of the study drug in terms of tumor dimension assessment. | Part 1 and Part 2 |
Not provided
Key Inclusion Criteria (Part 2):
Key Exclusion Criteria (Part 2):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States | ||
| Sarah Cannon Research Center |
Not provided
| ID | Term |
|---|---|
| C000595244 | ARRY-334543 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| British Columbia Cancer Agency- Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |