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Evaluating Tivozanib for Biliary Tract Cancers

This study is testing tivozanib, an oral drug, in adults with biliary tract cancers (cholangiocarcinoma or gallbladder cancer) that cannot be removed by surgery and have already been treated with chemotherapy. Researchers want to find the safest and most effective dose of tivozanib. They will also measure how many patients respond to the treatment, meaning their tumors shrink or stop growing. Tivozanib works by targeting proteins like VEGFR, which are involved in cancer growth. The study plans to enroll 31 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is not specified if it's randomized or blinded, but it aims to enroll 31 participants.
What's involved
You would take oral tivozanib daily for 21 days, followed by 7 days off, in 28-day cycles. You will have medical history, physical exams, blood and urine tests, heart function checks, and potentially a tumor biopsy.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured every 8 weeks after starting treatment.

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NCT04645160

Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~31 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Tivozanib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase II: Determine the overall response rate by RECIST of tivozanib in patients with cholangiocarcinoma who were previously treated with first-line therapy.
Measured over baseline, every 8 weeks post-treatment
+1 more outcome measured

Conditions

Cholangiocarcinoma
Bile Duct Neoplasm
Biliary Tract Malignancy

Explore related trials

CholangiocarcinomaGallbladder CarcinomaMalignant neoplasm of biliary tract

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Jonathan M Hernandez, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Kathleen M Smith, R.N.
[email protected]
(240) 858-3531
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hemoglobin \>= 8.0 g/dL
Absolute Neutrophil Count \>= 1,000/mcL
Platelets \>= 75,000/mcL
Total Bilirubin \<= 2.5 X institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) \<= 5 X institutional ULN
Creatinine Clearance \> 30
Serum Albumin (g/L) \> 28 8. Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP), excepting identified false-positive pregnancy test results as permitted in the note below.

Exclusion

Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable and on suppressive therapy, if indicated. For participants with HBV infection who are currently on treatment, they are eligible if they have an undetectable HBV viral load.
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 9. Significant cardiovascular disease, including: Active clinically symptomatic left ventricular failure, uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 3 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications.

What this trial measures

  • Phase II: Determine the overall response rate by RECIST of tivozanib in patients with cholangiocarcinoma who were previously treated with first-line therapy.baseline, every 8 weeks post-treatment

    Patients will be re-evaluated for response every 8 weeks after start of treatment. The Phase II clinical response rate (CR+PR) will be determined and reported along with a 95% confidence interval.

  • Phase I: Determine safety and establish the recommended Phase II dose (RP2D) of tivozanib in patients with cholangiocarcinoma who were previously treated with first-line chemotherapy.Every 8 weeks (Phase I only)

    List of adverse event frequency and grade. Patient DLTs will be counted and reported to determine the safety and tolerability of tivozanib and to establish the recommended Phase II dose (RP2D) using a standard 3+3 design.