Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (FOENIX-CCA4)

April 11, 2024 updated by: Taiho Oncology, Inc.

Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Caba, Argentina, 1431
        • Not yet recruiting
        • Cemic
        • Contact:
        • Principal Investigator:
          • Julieta Grasselli
      • Ciudad Autonoma de Buenos Aires, Argentina, AEB1280
        • Not yet recruiting
        • Hospital Britanico
        • Contact:
        • Principal Investigator:
          • Luciana Bella Quero
      • Rosario, Argentina, S2013
        • Not yet recruiting
        • Sanatorio de la Mujer
        • Contact:
        • Principal Investigator:
          • Cristina Nasurdi
  • Australia
      • Sydney, Australia, 2010
        • Not yet recruiting
        • St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
        • Principal Investigator:
          • Hao-Wen Sim
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Not yet recruiting
        • Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center
        • Principal Investigator:
          • Sanjeev Gill
  • Brazil
      • Cerqueira César, Brazil, 01246-000
        • Not yet recruiting
        • Instituto do Cancer do Estado de São Paulo
        • Contact:
        • Principal Investigator:
          • Camila Motta Venchiarutti Moniz
      • Curitiba, Brazil, 80530-010
        • Not yet recruiting
        • IOP - Instituto de Oncologia do Parana
        • Contact:
        • Principal Investigator:
          • Luciano Semensato Biela
      • Curitiba, Brazil, 81520-060
        • Not yet recruiting
        • Hospital Erasto Gaertner
        • Contact:
        • Principal Investigator:
          • Andressa Ribas
      • São José Do Rio Preto, Brazil, 15090-000
        • Not yet recruiting
        • Hospital de Base de Sao Jose do Rio Preto
        • Contact:
        • Principal Investigator:
          • Kathia Cristina Abadalla
      • São Paulo, Brazil, 01508-010
        • Not yet recruiting
        • Fundacao Antonio Prudente - A.C.Camargo Cancer Center
        • Contact:
        • Principal Investigator:
          • Tiago Felismino
  • China
      • Shanghai, China, 200123
        • Not yet recruiting
        • Shanghai East Hospital
        • Principal Investigator:
          • Jin Li
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong Provincial People's Hospitall
        • Contact:
        • Principal Investigator:
          • Dong Ma
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Not yet recruiting
        • Harbin Medical University - Cancer Hospital
        • Principal Investigator:
          • Yuxian Bai
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130028
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Principal Investigator:
          • Ying Cheng
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong University - Shandong Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Qi Dang
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital- Sichuan University
        • Contact:
        • Principal Investigator:
          • Dan Cao
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Not yet recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University
        • Principal Investigator:
          • Hongming Pan
        • Contact:
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico S. Orsola-Malpighi
        • Principal Investigator:
          • Giovanni Brandi
        • Contact:
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • IRCCS Humanitas Research Hospital
        • Principal Investigator:
          • Lorenza Rimassa
        • Contact:
      • Verona, Italy, 37134
        • Not yet recruiting
        • AOUI Verona - Ospedale Borgo Roma
        • Principal Investigator:
          • Davide Melisi
        • Contact:
  • Japan
      • Kashiwa-Shi, Japan, 277-0882
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
        • Principal Investigator:
          • Susumu Watanabe
      • Nagasaki-shi, Japan, 852-8501
        • Not yet recruiting
        • Nagasaki University Hospital
        • Principal Investigator:
          • Susumu Eguchi
        • Contact:
      • Nagoya-shi, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital
        • Principal Investigator:
          • Takashi Mizuno
        • Contact:
      • Osaka-Fu, Japan, 558-8585
        • Recruiting
        • Osaka Metropolitan University Hospital
        • Principal Investigator:
          • Hiroji Shinkawa
        • Contact:
    • Miyagi
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Recruiting
        • Dong-A University Hospital
        • Principal Investigator:
          • Sung Yong Oh
        • Contact:
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Principal Investigator:
          • Il Hwan Kim
        • Contact:
      • Daegu, Korea, Republic of, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Principal Investigator:
          • Won young Tak
        • Contact:
      • Jinju, Korea, Republic of, 52727
        • Recruiting
        • Gyeongsang National University Hospital
        • Principal Investigator:
          • Jung Hun Kang
        • Contact:
      • Seongnam, Korea, Republic of, 13532
        • Recruiting
        • CHA Bundang Medical Center
        • Principal Investigator:
          • Hongjae Chon
        • Contact:
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Yonsei University Health System - Severance Hospital
        • Principal Investigator:
          • Hye Jin Choi
        • Contact:
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea, St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Myung Ah Lee
  • Poland
      • Koszalin, Poland, 75-581
        • Not yet recruiting
        • Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
        • Principal Investigator:
          • Piotr Wysocki
        • Contact:
      • Lublin, Poland, 20-0920
        • Recruiting
        • Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
        • Principal Investigator:
          • Agata Chrzanowska-Kapica
        • Contact:
      • Otwock, Poland, 05-400
        • Not yet recruiting
        • Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
        • Principal Investigator:
          • Cezary Szcylik
        • Contact:
      • Warszawa, Poland, 02-034
        • Recruiting
        • Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
        • Principal Investigator:
          • Lucjan Wyrwicz
        • Contact:
  • Portugal
      • Lisboa, Portugal, 1400-038
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
        • Principal Investigator:
          • Catarina Abreu
        • Contact:
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Teresa Macarulla Mercade
      • Barcelona, Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
        • Contact:
        • Principal Investigator:
          • Berta Laquente Saez
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Principal Investigator:
          • Andres J. Munoz Martin
        • Contact:
          • Phone Number: 0034 91 586 81 61
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Principal Investigator:
          • Angela Lamarca
        • Contact:
      • Madrid, Spain, 28043
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Jorge Adeva Alfonso
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)
        • Principal Investigator:
          • Mariano Ponz-Sarvise
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • Clínica Universidad de Navarra
        • Contact:
        • Principal Investigator:
          • Mariano Ponz-Sarvise
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Not yet recruiting
        • University of California San Diego UCSD - Moores Cancer Center
        • Principal Investigator:
          • Burgoyne Adam
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Principal Investigator:
          • Philip Philip
    • Ohio
      • Canton, Ohio, United States, 44718
    • Texas
      • Abilene, Texas, United States, 79606-5208
        • Recruiting
        • Texas Oncology
        • Contact:
        • Principal Investigator:
          • Melynk Anton
      • Dallas, Texas, United States, 75203
        • Recruiting
        • The Liver Institute at Methodist Dallas Medical Center
        • Principal Investigator:
          • Parvez Mantry
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Center for Oncology and Blood Disorders
        • Principal Investigator:
          • Camacho Luis
        • Contact:
        • Contact:
          • Phone Number: 833-254-6829

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
  2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement
  3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
  4. Documentation of radiographic disease progression on the most recent prior therapy
  5. Measurable disease
  6. performance status 0 or 1
  7. Adequate organ function

Exclusion Criteria:

  1. History or current evidence of calcium and phosphate homeostasis disorder
  2. Current evidence of clinically significant retinal disorder

  3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:

    1. 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
    2. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
    3. 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
    4. 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.
    5. Patients with prior FGFR-directed therapy

  4. A serious illness or medical condition(s) including (but not limited to) the following:

    1. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month
    2. Known acute systemic infection
    3. 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
    4. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.
    5. 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.
  5. 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.
  6. Pregnant or lactating female.
  7. Known hypersensitivity or severe reaction to futibatinib or its excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm A
TAS-120 (20mg) tablets, oral; 21-day cycle
Drug: TAS-120
TAS-120 is an oral FGFR inhibitor
Other Names:
  • Futibatinib
Experimental: Treatment Arm B
TAS-120 (16mg) tablets, oral; 21-day cycle
Drug: TAS-120
TAS-120 is an oral FGFR inhibitor
Other Names:
  • Futibatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR by independent central review
Time Frame: 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
12 months after the study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DoR by independent review
Time Frame: 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
up to 12 months after the study completion
PFS by independent review
Time Frame: 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
up to 12 months after the study completion
ORR per Investigator assessment
Time Frame: 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).
up to 12 months after the study completion
DoR per Investigator assessment
Time Frame: 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
up to 12 months after the study completion
PFS per Investigator assessment
Time Frame: 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
up to 12 months after the study completion
OS
Time Frame: 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.
up to 12 months after the study completion
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Time Frame: 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.
up to 12 months after the study completion
Change from Baseline in Quality of life as assessed by EORTC QLQ-C30
Time Frame: 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
up to 12 months after the study completion
Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D )
Time Frame: 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.
up to 12 months after the study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAS-120-205
  • 2023-503665-39 (EudraCT Number)
  • 2022-9400 (Other Identifier: Japan PMDA CTN Receipt Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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