Phase 2 Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with biliary tract cancer (either cholangiocarcinoma or gallbladder cancer), confirmed through a tissue or cell sample from a biopsy or surgery.
• People whose cancer cannot be surgically removed.
• People who have already received a first round (first-line) of chemotherapy treatment for their cancer.
• People whose cancer can be measured using standard imaging criteria (to track whether it responds to treatment).
• People aged 18 or older.
• People who are well enough to carry out basic daily activities, based on a standard medical scale (ECOG score of 0, 1, or 2 — confirm with trial site).
• People whose blood test results show that their blood counts, liver function, kidney function, and protein levels meet certain minimum health thresholds (the trial site will assess this).
• People who are not pregnant at the time of screening — a pregnancy test will be required for anyone who could potentially become pregnant. (Note: this cancer can sometimes cause false-positive pregnancy tests, and the trial has a process to check for this.)
• All participants must agree to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) before joining, throughout the trial, and for one month after treatment ends.
• People who are able to understand the study and are willing to sign a written consent form.
• People who are willing to also enrol in a separate tissue collection study (protocol 13C0176).

Who may not be able to join:

• People who have had chemotherapy, targeted therapy, or radiation therapy within the 2 weeks before starting the trial drug.
• People who have previously been treated with tivozanib (the drug being studied in this trial).
• People who have had a serious liver condition called hepatic encephalopathy (brain problems caused by liver disease) in the past 12 months, or who take certain medications to manage this condition.
• People who have not fully recovered from surgery, or who have had major surgery within 4 weeks before starting the trial drug.
• People who have had another cancer in the past 3 years, with some exceptions — certain skin cancers, early-stage cervical changes, a type of slow-growing blood cancer (chronic lymphocytic leukaemia), or thyroid cancer may still be eligible (confirm with trial site).
• People who currently have an active second cancer, with similar exceptions as above.
• People who have had an allergic reaction or known sensitivity to tivozanib or similar medicines.
• People with an uncontrolled ongoing illness, serious infection requiring treatment, or a mental health or personal situation that would make it difficult to follow the study requirements. (Some exceptions apply for people living with HIV, hepatitis B, or hepatitis C who have their condition well managed — confirm with trial site.)
• People with serious heart problems, including active heart failure, a heart attack or severe chest pain in the past 3 months, dangerous heart rhythm problems, or heart rhythm problems requiring medication.
• People with blood pressure that is not controlled (150/90 mmHg or higher). People with a history of high blood pressure may still be considered if it is well managed on a stable medication dose (confirm with trial site).
• People with serious blood, digestive, clotting, or vascular disorders.
• People who have had gastrointestinal bleeding (such as from stomach ulcers or swollen veins in the oesophagus) within the past 3 months.
• People with a complex blockage in the bile ducts that requires drainage tubes at more than one level of the biliary system, or who need an external drainage device.
• People who have had more than one episode of bile duct infection (cholangitis) in the 3 months before joining.
• People taking strong blood-thinning or anti-clotting medications, with some exceptions (low molecular weight heparin, aspirin, and certain blood thinners called factor Xa inhibitors may be permitted — confirm with trial site).
• People who are pregnant or breastfeeding, as the trial drug may be harmful to a developing baby or infant.

Important: Always verify eligibility with the trial site directly before applying.