Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

NCT05727176 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: TAS-120-2052023-503665-392022-9400
• Study Type: interventional
• Target: 120
• Locations: 13 countries
• Sites: 65

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.

Conditions

Gene Rearrangement; Advanced Cholangiocarcinoma; FGFR2 Fusions

Keywords

Futibatinib; Advanced cholangiocarcinoma; cholangiocarcinoma; FGFR2; Fusion; Rearrangemen; TAS-120

Outcome Measures

Primary Outcomes (1)

• ORR by independent central review

  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 Outcomes (9)

• DoR by independent review

  up to 12 months after the study completion

• PFS by independent review

  up to 12 months after the study completion

• ORR per Investigator assessment

  up to 12 months after the study completion

• DoR per Investigator assessment

  up to 12 months after the study completion

• PFS per Investigator assessment

  up to 12 months after the study completion

Study Arms (2)

Treatment Arm A

EXPERIMENTAL

TAS-120 (20mg) tablets, oral; 21-day cycle

Drug: TAS-120

Treatment Arm B

EXPERIMENTAL

TAS-120 (16mg) tablets, oral; 21-day cycle

Drug: TAS-120

Interventions

TAS-120 DRUG

TAS-120 is an oral FGFR inhibitor

Also known as: Futibatinib

Treatment Arm A; Treatment Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (65)

University of California San Diego UCSD - Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Tampa General Hospital Cancer Institute

Tampa, Florida, 33606, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

WITHDRAWN

Texas Oncology

Abilene, Texas, 79606-5208, United States

RECRUITING

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

Texas Oncology Methodist DFW

Dallas, Texas, 75230, United States

RECRUITING

Texas Onc Methodist (Charlton)

Dallas, Texas, 75237, United States

RECRUITING

Texas Oncology - Northeast

Denton, Texas, 76201, United States

RECRUITING

Center for Oncology and Blood Disorders

Houston, Texas, 77030, United States

WITHDRAWN

Hospital Britanico

Buenos Aires, AEB1280, Argentina

RECRUITING

CEMIC

CABA, 1431, Argentina

RECRUITING

Sanatorio de la Mujer

Rosario, S2013, Argentina

RECRUITING

St Vincent's Hospital Sydney - The Kinghorn Cancer Centre

Sydney, New South Wales, 2010, Australia

RECRUITING

Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center

Melbourne, Victoria, 3004, Australia

RECRUITING

St John of God Subiaco Hospital

Subiaco, Western Australia, 6008, Australia

RECRUITING

Instituto do Cancer do Estado de Sao Paulo

Cerqueira César, 01246-000, Brazil

RECRUITING

IOP - Instituto de Oncologia do Parana

Curitiba, 80530-010, Brazil

RECRUITING

Hospital Erasto Gaertner

Curitiba, 81520-060, Brazil

RECRUITING

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, 15090-000, Brazil

RECRUITING

Fundacao Antonio Prudente - A.C.Camargo Cancer Center

São Paulo, 01508-010, Brazil

RECRUITING

Grand River Hospital - Grand River Regional Cancer Centre (GRRCC)

Kitchener, OH, N2G 1G3, Canada

RECRUITING

Sunnybrook Health Sciences Center

Toronto, OH, M4M 3N5, Canada

RECRUITING

University of Toronto

Toronto, OH, M5G 2M9, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Guangdong Provincial People's Hospitall

Guangzhou, Guangdong, 510080, China

RECRUITING

Harbin Medical University - Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Jiangsu Provance Hospital

Nanjing, Jiangsu, 212028, China

NOT YET RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130028, China

RECRUITING

Shandong University - Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Zhongahan Hospital Fudan unversity

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

West China Hospital- Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, Zhejiang, 310016, China

RECRUITING

Shanghai Gobroad Cancer Hospital China Pharmaceutical University

Shanghai, 200123, China

RECRUITING

Tongji University Shanghai East Hospital

Shanghai, China

RECRUITING

The University of Hong Kong

Hong Kong Island, 999077, Hong Kong

RECRUITING

The Chinese University of Hong Kong Prince of Wales Hospital

New Territories, 999077, Hong Kong

RECRUITING

Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

RECRUITING

IRCCS Humanitas Research Hospital

Rozzano, 20089, Italy

RECRUITING

AOUI Verona - Ospedale Borgo Roma

Verona, 37134, Italy

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa-Shi, 277-0882, Japan

RECRUITING

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

RECRUITING

Nagoya University Hospital

Nagoya, 466-8560, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka-Fu, 558-8585, Japan

RECRUITING

Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika

Koszalin, 75-581, Poland

WITHDRAWN

Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli

Lublin, 20-0920, Poland

WITHDRAWN

Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.

Otwock, 05-400, Poland

RECRUITING

Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie

Warsaw, 02-034, Poland

RECRUITING

Fundação Champalimaud

Lisbon, 1400-038, Portugal

RECRUITING

Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

RECRUITING

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

RECRUITING

Dong-A University Hospital

Busan, 49201, South Korea

WITHDRAWN

Kyungpook National University Hospital

Daegu, 41944, South Korea

RECRUITING

Gyeongsang National University Hospital

Jinju, 52727, South Korea

RECRUITING

CHA Bundang Medical Center

Seongnam, 13532, South Korea

RECRUITING

Yonsei University Health System - Severance Hospital

Seoul, 03722, South Korea

RECRUITING

The Catholic University of Korea, St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals

Barcelona, 08908, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

RECRUITING

Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)

Madrid, 28027, Spain

RECRUITING

Hospital Universitario Fundación Jimenez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de octubre

Madrid, 28043, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

futibatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Taiho Oncology, INC

CONTACT

+1 844-878-2446; medicalinformation@taihooncology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 14, 2023
• Study Start: July 5, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7); JP (5); ES (7); IT (3); PL (4); BR (5); AR (3); PT (2); US (10); CN (10); CA (4); HK (2); AU (3)