A Study of ARRY-380 in Patients With Advanced HER2+ Cancer

NCT00650572 Phase 1 COMPLETED

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).

Details

Lead sponsor	Seagen Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	50
Start date	2008-05
Completion	2013-03

Conditions

• Cancer

Interventions

• ARRY-380, HER2 inhibitor; oral

Primary outcomes

• 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
• Assess amplification/expression of HER2 in archival and tumor tissues. — Part 2, one year

Countries

United States, Canada