A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols
This is an open-label multi-center, multi-national rollover protocol to allow continued
access to tivozanib for subjects who have participated in other tivozanib (monotherapy or
combination) protocols, who are tolerating study drug, and displaying clinical benefit.
Enrollment to this protocol will remain open to subjects who participate in current and
future protocols with tivozanib. The end of the study is the last treatment visit of the
last subject at the last site. Enrollment in this protocol will continue until tivozanib
becomes commercially available in the country where the subject is being treated. If a
subject is experiencing clinical benefit from tivozanib when the study is discontinued, the
sponsor will make every effort to assist the subject in obtaining commercially available
tivozanib.
This rollover protocol will be open to eligible subjects on current and future protocols
with tivozanib. The number of subjects who will enroll is dependent upon the number of
subjects enrolled in tivozanib protocols that tolerate the drug, display clinical benefits,
and are willing to participate.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess long-term safety and tolerability of tivozanib in subjects who continue on tivozanib, in accordance with the parent protocol.
Patients are assessed for safety and tolerability on Day 1 of each cycle via Adverse Event assessments, Study Drug diary, concomitant medications review, blood pressure, hematology and serum chemistry labs, urinalysis with microscopic test as well as disease assessment completed at end of Cycle 2 and every even numbered cycles. All assessments are made in accordance to the protocol of the parent study in which the patient had participated in before enrolling in the AV-951-09-901 rollover study.
24 Months
Yes
Anna Berkenblit, MD
Study Director
AVEO Pharmaceuticals, Inc.
United States: Food and Drug Administration
AV-951-09-901
NCT01369433
June 2010
June 2013
Name | Location |
---|---|
Stanford University | Stanford, California 94305 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Associates in Oncology/Hematology | Rockville, Maryland 20850 |
Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
Kansas City, Kansas 66160 | |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Denver, Colorado | |
Charlotte, North Carolina | |
Indianapolis, Indiana | |
Lebanon, New Hampshire | |
Las Vegas, Nevada 89109 | |
Jackson, Mississippi | |
Coastal Bend Cancer Center | Corpus Christi, Texas 78404 |
Medical Oncology LLC | Baton Rouge, Louisiana 70809 |
Sarah Cannon Research Institute (SCRI) | Nashville, Tennessee 37203 |
Translational Genomics Research Institute (TGen) | Scottsdale, Arizona 85258 |
Horizon Oncology Research, Inc. | Lafayette, Indiana |
Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD and Janet Burroff MD APMC | Metairie, Louisiana |
Institute of Urologic Oncology | Los Angeles, California 90024 |
H. Lee Moffitt Cancer Center & Research Institute Hospital, Inc | Tampa, Florida 33612 |
The OU Cancer Institute | Oklahoma City, Oklahoma 73117 |