NCT00650572

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	ARRY-380, HER2 inhibitor; oral	Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2008-04-02
• Last updated: 2020-05-07

Locations

4 sites across 2 countries: United States, Canada