Testing TAS-120 for advanced cholangiocarcinoma

Exclusion

• −Known hypersensitivity or severe reaction to futibatinib or its excipients.
• −Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month
• −History or current evidence of calcium and phosphate homeostasis disorder
• −Current evidence of clinically significant retinal disorder
• −Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:
• −Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
• −Any non investigational anticancer therapy within 3 weeks or have not recovered from side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more → of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer
• −Patients with prior FGFR-directed therapy
• −A serious illness or medical condition(s) including (but not limited to) the following:
• −Known acute systemic infection
• −Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV New York Heart Association \[NYHA\] Classification) within the previous 2 months; if \>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms
• −Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.
• −Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → would make the patient inappropriate for entry into this study.
• −Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the SponsorSponsorThe organisation responsible for the study overall.Read more → prior to patient enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• −Pregnant or lactating female.
• −Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
• −Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.