A Study of ARRY-380 in Patients With Advanced HER2+ Cancer
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).
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 1, one year; Part 2, one year ]
- Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1, one year ]
- Characterize the pharmacokinetics of the study drug. [ Time Frame: Part 2, one year ]
- Assess amplification/expression of HER2 in archival and tumor tissues. [ Time Frame: Part 2, one year ]
- Characterize the pharmacokinetics of the study drug. [ Time Frame: Part 1, one year ]
- Assess changes in tumor markers. [ Time Frame: Part 1, one year ]
- Assess the efficacy of study drug in terms of tumor response and duration of response. [ Time Frame: Part 1, one year; Part 2, one year ]
- Assess expression of growth factor pathway proteins in archival and tumor tissues. [ Time Frame: Part 2, one year ]
|Study Start Date:||May 2008|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Drug: ARRY-380, HER2 inhibitor; oral
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650572
|United States, Colorado|
|The University of Colorado Cancer Center|
|Aurora, Colorado, United States|
|United States, Texas|
|The University of Texas, MD Anderson Cancer Center|
|Houston, Texas, United States, 77230|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|