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About
This research study is evaluating a drug called cabozantinib as a possible treatment cancer of the bile duct. Cabozantinib is a drug that targets specific pathways inside the cells of the body. By blocking the c-MET and VEGFR2 pathways from sending signals, cabozantinib may prevent cells from multiplying. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to stop the growth of bile duct cancer.
In this research study, the investigators are looking to see how well cabozantinib works in slowing the growth of bile duct cancer. The investigators are also assessing the safety and tolerability of cabozantinib in participants with this type of cancer.
Full description
After the screening procedures confirm that the participants are eligible to participate in the research study:
A two-stage design will be employed in this study where at least 9 of the 20 patients enrolled in the first stage need to be progression-free at 16 weeks before the second stage can proceed. If this criterion is met, an additional 24 patients will be enrolled in the second stage for a total of 44 patients in the study. Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
In this research study, the participant will be given a study drug-dosing diary for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks), during which time the participant will be taking the study drug, cabozantinib daily. The diary will also include special instructions for taking the study drug(s).
The participant will continue to take cabozantinib for as long as it is tolerated without any unacceptable side effects and the cancer does not get worse.
The following tests and procedures will be done during the research study:
Cycle 1 - On days 1, 8 and 15
Additional research procedures during Cycle 1:
Cycles 2-3 - On days 1 and 15
Cycle 4 and Beyond: Day 1 ONLY
The following tests will be done every 2 cycles during the research study:
Planned Follow-up:
The participant will return to the clinic between 30-37 days after the last dose of cabozantinib for the following tests and procedures:
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19 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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