A Phase 2 and Biomarker Study of Tivozanib in Subjects With Advanced Renal Cell Carcinoma
This is a Phase 2, open-label, single arm, multi-center, study of orally administered
tivozanib to approximately 100 subjects with advanced renal cell carcinoma (RCC). This study
is designed to evaluate biomarkers in blood and archived tissue samples, and their
correlation with clinical activity and/or treatment-related toxicity in subjects with
advanced RCC, and estimate the percentage of tivozanib-treated subjects who are
progression-free at 6 months, overall response rate (ORR), progression free survival (PFS),
safety and tolerability, and pharmacokinetics (PK). Subjects will be stratified by histology
(clear cell vs. non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤
30% of the entire study population.
Study enrollment is anticipated to complete in approximately 9 months. Treatment duration is
estimated to last approximately 6 months from the subject's first dose of tivozanib with a
follow-up period of 30 days. After 6 months, treatment with tivozanib may continue by
participation in a rollover protocol (AV-951-09-901). Maximum duration of subject
participation in this Phase 2 study is approximately 8 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate archived tumor tissue samples and their correlation with clinical activity and/or treatment related toxicity.
These biomarkers may include but are not limited to: CD68, HIF (hypoxia induced factor)1/HIF2, VEGF A, VEGF-B, VEGF-C, VEGF-D, HGF (hepatocyte growth factor), CAIX, and PLGF (placental growth factor) levels and a biomarker signature based on transcriptional profiles.
Archived tumor tissue will be collected from subjects that meet eligibility criteria and will be enrolled on the study.
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Rocky Mountain Cancer Center||Denver, Colorado 80218|
|Medical Oncology, LLC||Baton Rouge, Louisiana 70808|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Ohio State University||Columbus, Ohio 43210|
|Cancer & Hematology Centers of Western Michigan||Grand Rapids, Michigan 49546|
|The West Clinic||Memphis, Tennessee 38120|
|The Jones Clinic||Germantown, Tennessee 38138|
|David Geffen School of Medicine at UCLA||Los Angeles, California 90095|
|North Mississippi Hematology & Oncology Associates, Ltd.||Tupelo, Mississippi 38801|
|Cancer Center of Kansas||Wichita, Kansas 67214|
|Coastal Bend Cancer Center||Corpus Christi, Texas 78404|
|St. Francis Cancer Research Foundation||Beech Grove, Indiana 46107|
|Texas Oncology-Austin North||Austin, Texas 78759|
|Southern Cancer Center||Mobile, Alabama 36608|
|University of North Carolina, Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599|
|Comprehensive Cancer Centers of Nevada & US Oncology Research||Las Vegas, Nevada 89169|
|Providence Health and Services||Burbank, California 91505|
|Mary Hitchcock Memorial Hospital, NH||Lebanon, New Hampshire|
|Texas Oncology-Baylor, Charles A. Sammons Cancer Center||Dallas, Texas|