Study on the Effectiveness of Tivozanib in Treating Biliary Tract Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04645160

Provider View

This clinical trial is testing a new drug, tivozanib, to see if it can help slow down or stop the growth of bile duct cancer (cholangiocarcinoma) in adults who have already tried chemotherapy. The study aims to find the safest and most effective dose of tivozanib.

Patient Parameters

Program Overview

Bile duct cancer, also known as cholangiocarcinoma, is a serious type of cancer with limited treatment options. This study is exploring whether a new drug called tivozanib can help control the growth of this cancer. Researchers want to find out the best dose of tivozanib and how well it works in patients who have already received chemotherapy but cannot have surgery to remove the cancer.

Description

Biliary tract cancers, including cholangiocarcinoma and gallbladder cancer, are aggressive and difficult to treat. The standard first-line treatment is a combination of chemotherapy drugs, but it only works for about 22% of patients, and the cancer often progresses within 8 months.

Researchers have identified a protein called XPO7 that is linked to poor outcomes in these cancers. Tivozanib, a drug that targets a related protein called SLK, has shown promise in laboratory tests and animal studies. It has been effective in reducing tumor growth in these models.

This study aims to evaluate tivozanib as a treatment option for patients with biliary tract cancer who have already tried chemotherapy. The study will determine how well tivozanib works in shrinking tumors and improving patient outcomes.

Participants will take tivozanib by mouth once a day for 21 days, followed by a 7-day break, in 28-day cycles. They will continue taking the drug until they experience severe side effects, their cancer worsens, or they become pregnant. Participants will monitor their blood pressure at home and keep a diary of their medication and any side effects.

Study visits will occur before each new cycle and every 8 weeks. A follow-up visit will take place 30 days after treatment ends, with additional check-ins at 6 and 12 months, and then annually.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with confirmed biliary tract cancer (cholangiocarcinoma or gallbladder cancer) that cannot be removed by surgery.
  • Must have received prior chemotherapy treatment.
  • Cancer must be measurable by standard criteria.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate organ and bone marrow function, including:
    • Hemoglobin of at least 8.0 g/dL
    • Neutrophil count of at least 1,000/mcL
    • Platelet count of at least 75,000/mcL
    • Total bilirubin no more than 2.5 times the normal limit
    • Liver enzymes (AST/ALT) no more than 5 times the normal limit
    • Creatinine clearance greater than 30
    • Serum albumin greater than 28 g/L
  • Negative pregnancy test for individuals of childbearing potential.
  • Willingness to use effective contraception during the study and for one month after treatment.
  • Ability to understand and sign informed consent.
  • Willingness to participate in a related tissue collection study.

Exclusion Criteria

  • Recent chemotherapy, small molecule, or radiation therapy within 2 weeks before starting the study drug.
  • Previous treatment with tivozanib.
  • History of liver-related brain issues or need for medications to prevent or control these issues.
  • Incomplete recovery from recent surgery or major surgery within 4 weeks before starting the study drug.
  • Other cancers within the last 3 years, except for certain skin cancers or treated cervical cancer.
  • Current active second primary cancer, except for certain skin cancers or chronic lymphocytic leukemia not needing treatment.
  • Allergic reactions to similar drugs as tivozanib.
  • Uncontrolled illnesses or infections requiring treatment.
  • Significant heart disease or uncontrolled high blood pressure.
  • Blood disorders or recent gastrointestinal bleeding.
  • Complex bile duct issues requiring multiple stents or drainage.
  • Repeated episodes of bile duct infections.
  • Use of certain blood thinners, except for specific types.
  • Pregnant or breastfeeding individuals due to potential risks to the baby.

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