A Phase II and Biomarker Study of Tivozanib With Gemcitabine Addition Upon Progression in Patients With Metastatic Refractory Renal Cell Carcinoma
If you agree to participate in this study you will be asked to undergo some screening tests
and procedures to confirm that you are eligible. Many of these tests and procedures are
likely to be part of regular cancer care and may be done even if it turns out that you do
not take part in this study. If you have had some of these tests and procedures recently,
they may or may not need to be repeated. The screening process will include the following:
medical history, physical examination, measurement of vital signs, performance status
assessment, electrocardiogram (EKG), echocardiogram (ECHO), CT or MRI, routine blood tests,
urine sample, blood pregnancy test. If these tests show that you are eligible to participate
in the research study, you will begin the study treatment. If you do not meet the
eligibility criteria, you will not be able to participate in this research study.
This study is broken into two segments. In the first segment, you will receive tivozanib
alone. Every 28 days in this study is called a study "cycle". You will come to clinic once
every 28 days (once a month), on 'day 1' of each 28 day cycle.
Tivozanib is a pill that you take by mouth. You will take it once per day, in the morning,
with a glass of water, with or without food. You will take tivozanib days 1-21 (the first
three weeks) of each 28 day treatment cycle. You will be given a Study Drug Administration
Diary to keep a brief record of the date and time when you take your dose of tivozanib. The
study staff will explain to you how to complete your diary. This will be reviewed during yur
visits by your doctor or a member of the study staff. This diary will be collected at your
visit at the end of each cycle, and a new one will be given to you at the start of the next
cycle. You will also have a pre-dose research blood draw (approximately 8 teaspoons of
blood will be drawn) prior to your first dose of tivozanib, and after your first cycle of
tivozanib. Your samples will not have personal information about you (such as your name and
address) on them.
On Day 1 of every cycle you will have: a medical history, physical exam, measurement of your
vital signs, performance status assessment, routine blood tests to monitor your health,
urine sample. Every other cycle (prior to cycle 3, 5, 7 etc). you will have a CT or MRI
scan, EKG, ECHO.
If your cancer gets worse while receiving tivozanib alone you may be eligible to participate
in segment 2 of the study and receive tivozanib in combination with gemcitabine. You will
come to the clinic on days 1 and 8 of each 28 day cycle.
Gemcitabine will be given through a vein (intravenously, or IV) over a period of 30 minutes
at the study clinic. This is called an infusion. You will receive the gemcitabine on days 1
and 8 of each treatment cycle.
You will also have a pre-dose research blood draw (approximately 8 teaspoons of blood will
be drawn) prior to your first cycle of tivozanib and gemcitabine in combination, after your
first 28 days cycle of tivozanib and gemcitabine in combination, and if your cancer gets
worse while receiving tivozanib and gemcitabine in combination. Your samples will not have
personal information about you (such as your name and address) on them.
If your doctor determines it is safe for you to have a biopsy, you will undergo a fresh
tumor biopsy at the following time points: Prior to receiving your first 28 day cycle of
tivozanib and gemcitabine in combination; and after two 28 day cycles (roughly 2 months) of
receiving tivozanib and gemcitabine in combination.
On Days 1 and 8 and at the end of study treatment you will undergo a medical history,
physical examination, measurement of vital signs, performance status assessment, routine
blood tests and a urine sample.
If an unexpected or unwanted event happens during the study, you may be asked to have some
extra tests or measurements. Some of the tests or measurements done during the study may
have to be repeated if the results are not usable or are abnormal. If additional visits are
required during your participation in this study, your study doctor may perform the
following procedures and evaluations: medical history, vital sign measurements, physical
exam, ECG, performance status, blood and urine tests and/or a review of your study drug
We would like to keep track of your medical condition indefinitely. If we do not hear from
you, we would like to do this by calling no more than every three months to see how you are
doing. Keeping in touch with you and checking your condition helps us look at the long-term
effects of the research.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate Activity and Toxicity of Tivozanib in mRCC Subjects
To evaluate the activity and toxicity of tivozanib in mRCC study participants who failed at least 1 prior VEGF-targeted therapy.
Toni Choueiri, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|