Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (FOENIX-CCA4)
Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement
About this trial
This is an interventional treatment trial for Advanced Cholangiocarcinoma focused on measuring Futibatinib, Advanced cholangiocarcinoma, cholangiocarcinoma, FGFR2, Fusion, Rearrangemen, TAS-120
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement Received at least one prior systemic gemcitabine and platinum-based regimen for CCA Documentation of radiographic disease progression on the most recent prior therapy Measurable disease performance status 0 or 1 Adequate organ function Exclusion Criteria: 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: 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 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 effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer 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. Patients with prior FGFR-directed therapy A serious illness or medical condition(s) including (but not limited to) the following: Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month 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 Investigator 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 Sponsor prior to patient enrollment. Pregnant or lactating female. Known hypersensitivity or severe reaction to futibatinib or its excipients.
Sites / Locations
- University of California San Diego UCSD - Moores Cancer Center
- Henry Ford Health System
- Gabrail Cancer Center ResearchRecruiting
- Texas Oncology
- The Liver Institute at Methodist Dallas Medical CenterRecruiting
- Center for Oncology and Blood Disorders
- CEMIC
- Hospital Britanico
- Sanatorio de la Mujer
- Instituto do Cancer do Estado de Sao Paulo
- IOP - Instituto de Oncologia do Parana
- Hospital Erasto Gaertner
- Hospital de Base de Sao Jose do Rio Preto
- Shanghai East Hospital
- Policlinico S. Orsola-Malpighi
- IRCCS Humanitas Research Hospital
- AOUI Verona - Ospedale Borgo Roma
- National Cancer Center Hospital EastRecruiting
- Nagasaki University Hospital
- Nagoya University HospitalRecruiting
- Osaka Metropolitan University Hospital
- Inje University Haeundae Paik Hospital
- Dong-A University HospitalRecruiting
- Kyungpook National University HospitalRecruiting
- Gyeongsang National University HospitalRecruiting
- CHA Bundang Medical CenterRecruiting
- Yonsei University Health System - Severance Hospital
- The Catholic University of Korea, St. Mary's Hospital
- Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
- Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
- Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
- Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
- Fundação Champalimaud
- Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
- Hospital Vall d'Hebron
- Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario 12 de octubre
- Clinica Universidad de Navarra
- Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
- Taichung Veterans General Hospital
- Kaohsiung Medical University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Treatment Arm A
Treatment Arm B
TAS-120 (20mg) tablets, oral; 21-day cycle
TAS-120 (16mg) tablets, oral; 21-day cycle