Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
- Conditions
- Advanced CholangiocarcinomaFGFR2 FusionsGene Rearrangement
- Interventions
- Registration Number
- NCT05727176
- Lead Sponsor
- Taiho Oncology, Inc.
- Brief Summary
This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.
- Detailed Description
This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements. Eligible patients will be randomized on a 1:1 basis to the following study arms:
* Patients will receive futibatinib at an oral dose of 16 mg, administered daily (QD) on every day of a 21-day cycle.
* Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle.
Patients may continue to receive continuous futibatinib until documentation of progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met, whichever comes first.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm A TAS-120 TAS-120 (20mg) tablets, oral; 21-day cycle Treatment Arm B TAS-120 TAS-120 (16mg) tablets, oral; 21-day cycle
- Primary Outcome Measures
Name Time Method ORR by independent central review 12 months after the study completion defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR
- Secondary Outcome Measures
Name Time Method Change from Baseline in Quality of life as assessed by EORTC QLQ-C30 up to 12 months after the study completion Change from Baseline in quality of life as assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
PFS per Investigator assessment up to 12 months after the study completion defined as the time from date of randomization to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first
DoR by independent review up to 12 months after the study completion defined as time from the first documentation of response to the first documentation of objective tumor progression by ICR (per RECIST 1.1) or death due to any cause, whichever occurs first
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 up to 12 months after the study completion Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0. including serious adverse events (SAEs) and dose modifications.
PFS by independent review up to 12 months after the study completion defined as the time from date of randomization to the date of documentation of disease progression by ICR per RECIST (version 1.1, 2009) or date of death, whichever comes first
ORR per Investigator assessment up to 12 months after the study completion defined as proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST v1.1).
OS up to 12 months after the study completion defined as the time from the date of randomization until the date of death due to any cause.
DoR per Investigator assessment up to 12 months after the study completion defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first
Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D ) up to 12 months after the study completion Change from Baseline in Quality of Life as Assessed by European Quality of Life - 5 Dimensions-3 Levels (EQ-5D-3L) Scale Score.
Trial Locations
- Locations (57)
Hospital Universitario 12 de octubre
🇪🇸Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
St John of God Subiaco Hospital
🇦🇺Subiaco, Western Australia, Australia
Instituto do Cancer do Estado de Sao Paulo
🇧🇷Cerqueira César, Brazil
IOP - Instituto de Oncologia do Parana
🇧🇷Curitiba, Brazil
Hospital Erasto Gaertner
🇧🇷Curitiba, Brazil
Hospital de Base de Sao Jose do Rio Preto
🇧🇷São José Do Rio Preto, Brazil
Nagoya University Hospital
🇯🇵Nagoya-shi, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka-Fu, Japan
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam, Korea, Republic of
Yonsei University Health System - Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
🇵🇱Koszalin, Poland
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
🇵🇱Lublin, Poland
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
🇵🇱Otwock, Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
🇵🇱Warszawa, Poland
Fundação Champalimaud
🇵🇹Lisboa, Portugal
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
🇵🇹Lisbon, Portugal
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jimenez Díaz
🇪🇸Madrid, Spain
University of California San Diego UCSD - Moores Cancer Center
🇺🇸La Jolla, California, United States
Tampa General Hospital Cancer Institute
🇺🇸Tampa, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Texas Oncology
🇺🇸Abilene, Texas, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Texas Onc Methodist (Charlton)
🇺🇸Dallas, Texas, United States
Center for Oncology and Blood Disorders
🇺🇸Houston, Texas, United States
CEMIC
🇦🇷Caba, Argentina
Hospital Britanico
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Sanatorio de la Mujer
🇦🇷Rosario, Argentina
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
🇦🇺Sydney, New South Wales, Australia
Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center
🇦🇺Melbourne, Victoria, Australia
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
🇧🇷São Paulo, Brazil
Guangdong Provincial People's Hospitall
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University - Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Shandong University - Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
West China Hospital- Sichuan University
🇨🇳Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
🇨🇳Shanghai, China
Tongji University Shanghai East Hospital
🇨🇳Shanghai, China
The University of Hong Kong
🇭🇰Hong Kong Island, Hong Kong
The Chinese University of Hong Kong Prince of Wales Hospital
🇭🇰New Territories, Hong Kong
Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
IRCCS Humanitas Research Hospital
🇮🇹Rozzano, Italy
AOUI Verona - Ospedale Borgo Roma
🇮🇹Verona, Italy
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-Shi, Japan
Nagasaki University Hospital
🇯🇵Nagasaki-shi, Japan