Tivozanib for Biliary Tract Cancer
Trial Summary
What is the purpose of this trial?
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. ...
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy, small molecule, or radiation therapy within 2 weeks before starting the study drug. It's best to discuss your current medications with the trial team to ensure they don't interfere with the study.
How does the drug Tivozanib differ from other treatments for biliary tract cancer?
Tivozanib is unique because it is a targeted therapy that inhibits specific pathways involved in cancer growth, such as the vascular endothelial growth factor receptor (VEGFR), which is different from traditional chemotherapy that affects all rapidly dividing cells. This approach may offer a more personalized treatment option for patients with biliary tract cancer, especially those who do not respond to standard chemotherapy.12345
Research Team
Jonathan M Hernandez, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Adults over 18 with inoperable biliary tract cancer (BTC), including cholangiocarcinoma or gallbladder cancer, who have already tried at least one chemotherapy. They must be able to perform daily activities to a certain extent and have adequate organ function. Women of childbearing potential must test negative for pregnancy and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tivozanib orally once a day for 21 days per 28-day cycle, with dose adjustments as needed
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Tivozanib
Tivozanib is already approved in United States, European Union for the following indications:
- Renal cell carcinoma
- Renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor