Cancer
Conditions
Keywords
human epidermal growth factor receptor 2, epidermal growth factor receptor, EGFR, type I receptor tyrosine kinase
Brief summary
This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380. This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Completed). In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).
Interventions
DRUGARRY-380, HER2 inhibitor; oral
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Sponsors
Array BioPharma
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria (Part 1 and Part 2): * Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2). * Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2. * Additional criteria exist. Key
Exclusion criteria
(Part 1 and Part 2): * Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days). * Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug. * Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites). * Chemotherapy within 21 days prior to first dose of study drug. * Major surgery within 30 days prior to first dose of study drug. * Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C. * Additional criteria exist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess amplification/expression of HER2 in archival and tumor tissues. | Part 2, one year |
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. | Part 1, one year; Part 2, one year |
| Establish the maximum tolerated dose (MTD) of the study drug. | Part 1, one year |
| Characterize the pharmacokinetics of the study drug. | Part 2, one year |
Secondary
| Measure | Time frame |
|---|---|
| Assess expression of growth factor pathway proteins in archival and tumor tissues. | Part 2, one year |
| Assess the efficacy of study drug in terms of tumor response and duration of response. | Part 1, one year; Part 2, one year |
| Characterize the pharmacokinetics of the study drug. | Part 1, one year |
| Assess changes in tumor markers. | Part 1, one year |
Countries
Canada, United States
Outcome results
None listed