A Study of ARRY-380 in Patients With Advanced HER2+ Cancer
- Conditions
- Cancer
- Interventions
- Drug: ARRY-380, HER2 inhibitor; oral
- Registration Number
- NCT00650572
- Lead Sponsor
- Seagen Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARRY-380 ARRY-380, HER2 inhibitor; oral -
- Primary Outcome Measures
Name Time Method 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 Characterize the pharmacokinetics of the study drug. Part 2, one year Assess amplification/expression of HER2 in archival and tumor tissues. Part 2, one year Establish the maximum tolerated dose (MTD) of the study drug. Part 1, one year
- Secondary Outcome Measures
Name Time Method Assess expression of growth factor pathway proteins in archival and tumor tissues. Part 2, one year Characterize the pharmacokinetics of the study drug. Part 1, one year Assess changes in tumor markers. Part 1, 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
Trial Locations
- Locations (4)
The University of Texas, MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
The University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada