Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers (NCT04645160) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers
United States31 participantsStarted 2022-03-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants with histologically or cytologically confirmed biliary tract cancer (BTC) (cholangiocarcinoma or gallbladder cancer). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.
✓. Participants must have disease that is not amenable to resection.
✓. Participants must have had prior treatment with 1st line chemotherapy.
✓. Disease must be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
✓. Age \>=18 years.
✓. ECOG performance status \<= 2
✓. Adequate organ and marrow function as defined below:
✓. 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 criteria
✕. Chemotherapy, small molecule or radiation therapy within 2 weeks prior to administration of first dose of study drug.
What they're measuring
1
Phase II: Determine the overall response rate by RECIST of tivozanib in patients with cholangiocarcinoma who were previously treated with first-line therapy.
Timeframe: baseline, every 8 weeks post-treatment
2
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.
✕. History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (e.g., no lactulose, rifaximin, etc. if used for purposes of hepatic encephalopathy).
✕. Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
✕. Previous malignant disease other than the target malignancy within the last 3 years with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, chronic lymphocytic leukemia, or thyroid carcinoma.
✕. Current active second primary malignancy, other than skin carcinoma (basal or squamous cell carcinoma), chronic lymphocytic leukemia not requiring active treatment, or differentiated thyroid carcinoma.
✕. History of allergic reactions or known or suspected hypersensitivity attributed to compounds of similar chemical or biologic composition to tivozanib.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy (see exceptions below), or psychiatric illness/social situations that would limit compliance with study requirements