An Extension Protocol for Subjects Who Were Previously Enrolled in Other ARQ 197 Protocols
This is an open label extension protocol for patients who have been treated in previous ARQ
197 studies that have reached their designated end-dates. Patients enrolled in this
extension protocol will continue to receive either ARQ 197 as monotherapy or in combination
with other drug(s) at the same dose(s), and same schedule(s) in which they were originally
enrolled.
This extension study is designed to further evaluate the safety and tolerability of ARQ 197
monotherapy or in combination with other drug(s) when given to patients who tolerated
previous treatment well and may benefit from the continuing treatment. ARQ 197 will be
administered twice daily, orally, with meals (regardless of the original protocol
requirements).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To provide ongoing treatment with ARQ 197 for patients who have benefited from prior treatment with ARQ 197
No time frame
No
United States: Food and Drug Administration
ARQ 197-299
NCT01178411
August 2010
June 2014
Name | Location |
---|---|
New Britain, Connecticut 06052 | |
Albany, Georgia 31701 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Charlotte, North Carolina |