A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols
Status:
Terminated
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
Open-label, multi-center, multi-national rollover study to allow continued access to
tivozanib for subjects who have participated in other tivozanib (monotherapy or combination)
protocols. Eligible subjects will continue to receive tivozanib at the same dose and schedule
as per the original (parent) protocol. The length of time that a subject must be on the
parent protocol before rolling over to this protocol will be dictated by the (original)
parent protocol. Subjects will be seen by the investigator every 4 weeks (± 5 days). Adverse
events and blood pressure will be recorded. At the beginning of Cycle 1 and at the beginning
of every odd-numbered cycle (Cycle 3, Cycle 5, etc), clinical laboratory values will be
recorded. CT scans to assess disease will be performed at the end of even-numbered cycles
(Cycle 2, Cycle 4, etc).