Actively Recruiting
Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers
Led by National Cancer Institute (NCI) · Updated on 2026-05-07
31
Participants Needed
1
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Cholangiocarcinoma (CCA) is an aggressive cancer of the bile ducts. People with CCA have few treatment options and poor survival. Researchers want to see if a new drug can stop or slow CCA growth. Objective: To find the safest and most effective dose of tivozanib to treat CCA and learn its overall response rate. Eligibility: Adults ages 18 and older with CCA not removable with surgery and have been treated with at least one type of chemotherapy. Design: Participants will be screened with the following: * Medical history * Physical exam * Assessment of their ability to do daily activities * Medicine review * Blood tests, including thyroid function tests * Urine tests * Electrocardiogram, to check heart function * Pregnancy test, if needed * Tumor biopsy, if needed * Computed tomography scans * Magnetic resonance imaging, if needed Some screening tests may be repeated during the study. Participants will be asked to enroll in protocol #13C0176. This will allow any remaining tumor or blood samples to be used in future research. Participants will take tivozanib by mouth, once a day for 21 days per cycle or every other day per cycle. Each cycle is 28 days. They can take the drug until they have bad side effects, their CCA gets worse, or if they become pregnant. They will record their blood pressure twice daily at home. They will also keep a medication diary of each dose of tivozanib they take and any side effects. Participants will have study visits before starting each new cycle and every 8 weeks. They will also have a follow-up visit 30 days after treatment ends at NIH, or if they are unable to come to NIH by phone, videocall, or other NIH-approved platform. Then they will be contacted 6 and 12 months later, and then once a year.
CONDITIONS
Official Title
Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with confirmed biliary tract cancer (cholangiocarcinoma or gallbladder cancer) by tissue biopsy or archival sample
- Cancer that cannot be removed by surgery
- Prior treatment with first-line chemotherapy
- Measurable disease by RECIST 1.1 criteria
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Adequate organ and bone marrow function
- Negative pregnancy test for individuals who can become pregnant
- Agreement to use contraception during and one month after treatment
- Ability to understand and sign informed consent
- Willingness to enroll in tissue collection protocol 13C0176
You will not qualify if you...
- Chemotherapy, small molecule, or radiation therapy within 2 weeks before first dose of study drug
- Prior treatment with tivozanib
- History of hepatic encephalopathy in the past 12 months or needing medication for it
- Incomplete recovery from major surgery within 4 weeks before first dose
- Other cancers diagnosed in the last 3 years, except certain skin or thyroid cancers
- Current active second primary cancer (except certain skin, leukemia, or thyroid cancers)
- Allergy or suspected sensitivity to drugs similar to tivozanib
- Uncontrolled illness or infection that would limit study compliance
- Significant heart disease or uncontrolled high blood pressure
- Blood disorders or recent gastrointestinal bleeding within 3 months
- Complex biliary obstruction requiring multiple bile duct stents
- More than one episode of cholangitis in the past 3 months
- Use of therapeutic anti-coagulation or anti-platelet therapy except specified medications
- Pregnant or breastfeeding individuals due to potential harm to fetus or infant
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
K
Kathleen M Smith, R.N.
CONTACT
J
Jonathan M Hernandez, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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