The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (R/R CCA) to participate in a research study. The study will evaluate an investigational drug called tinengotinib as a possible treatment for R/R CCA. Tinengotinib is considered an investigational drug for use in this study because it has not been approved by the FDA. Tinengotinib is thought to work by preventing processes that contribute to further cell growth in tumors and also helps limit blood and nutrient supply to tumors in order slow tumor growth. The main purpose of this study is to learn how well tinengotinib works and the safety of tinengotinib compared with the study doctor’s choice of standard chemotherapy treatment. If you participate in the study you will be randomly assigned to receive either the study drug (tinengotinib) or the study doctor’s choice of standard treatment.
The study involves receiving the investigational drugs or standard treatment, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, talking to the study doctor, and answering questionnaires. Participation includes a screening visit, a treatment period where you will receive the study treatment in 28 day cycles, and a follow-up period after you stop taking the study treatment. How long you will be on the study depends on your ability to safely tolerate the study treatment, your response to the study treatment, and your and/or your study doctor’s decision for you to continue study treatment.
The investigational drug tinengotinib, as well as study related doctor's visits and laboratory tests, will be provided at no cost to you.
More information about this study can be found at https://www.clinicaltrials.gov/study/NCT05948475
Reimbursement-$85 Stipend per visit; Hotel up to $200 per night