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NCT05727176 | RECRUITING | Advanced Cholangiocarcinoma

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

Condition or disease

Advanced Cholangiocarcinoma

FGFR2 Fusions

Gene Rearrangement

Intervention/treatment

TAS-120

Phase

PHASE2

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
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements
Actual Study Start Date : 2023-07-05
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Location Details

NCT05727176

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California San Diego UCSD - Moores Cancer Center

THE JOLLA, California, United States, 92093

RECRUITING

United States, Florida

Tampa General Hospital Cancer Institute

Tampa, Florida, United States, 33606

RECRUITING

United States, Road cancer

Henry Ford Health System

Detroit, Road cancer, United States, 48202

WITHDRAWN

United States, Ohio

Gabrail Cancer Center Research

Canton, Ohio, United States, 44718

RECRUITING

United States, Texas

Texas Oncology

Abilene, Texas, United States, 79606-5208

RECRUITING

United States, Texas

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States, 75203

RECRUITING

United States, Texas

Texas Oncology Methodist DFW

Dallas, Texas, United States, 75230

RECRUITING

United States, Texas

Texas Onc Methodist (Charlton)

Dallas, Texas, United States, 75237

RECRUITING

United States, Texas

Texas Oncology - Northeast

Denton, Texas, United States, 76201

RECRUITING

United States, Texas

Center for Oncology and Blood Disorders

Houston, Texas, United States, 77030

RECRUITING

Argentina,

Cemic

CABA, Argentina, 1431

RECRUITING

Argentina,

Britain Hospital

Autonomous City of Buenos Aires, Argentina, AEB1280

RECRUITING

Argentina,

Women's Sanatorium

Rosario, Argentina, S2013

RECRUITING

Australia, New South Wales

St Vincent's Hospital Sydney - The Kinghorn Cancer Centre

Sydney, New South Wales, Australia, 2010

RECRUITING

Australia, Victoria

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

Melbourne, Victoria, Australia, 3004

RECRUITING

Australia, Western Australia

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia, 6008

RECRUITING

Brazil,

SAO PAULO STATE CANCER INSTITUTE

Cerqueira César, Brazil, 01246-000

RECRUITING

Brazil,

IOP - Parana Oncology Institute

Curitiba, Brazil, 80530-010

RECRUITING

Brazil,

Erasto Gaertner Hospital

Curitiba, Brazil, 81520-060

RECRUITING

Brazil,

BASE HOSPITAL OF SAO JOSE DO RIO PRETO

São José do Rio Preto, Brazil, 15090-000

RECRUITING

Brazil,

Foundation Antonio Prudente - A.C.Camargo Cancer Center

São Paulo, Brazil, 01508-010

NOT YET RECRUITING

China, Guangdong

Guangdong Provincial People's Hospitall

Guangzhou, Guangdong, China, 510080

NOT YET RECRUITING

China, Heilongjiang

Harbin Medical University - Cancer Hospital

Harbin, Heilongjiang, China,

NOT YET RECRUITING

China, Jilin

Jilin Cancer Hospital

Changchun, Jilin, China, 130028

NOT YET RECRUITING

China, Shandong

Shandong University - Shandong Cancer Hospital

Women, Shandong, China, 250117

NOT YET RECRUITING

China, Sichuan

West China Hospital- Sichuan University

Chengdu, Sichuan, China, 610041

NOT YET RECRUITING

China, Zhejiang

Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, Zhejiang, China, 310016

NOT YET RECRUITING

China,

Shanghai Gobroad Cancer Hospital China Pharmaceutical University

Shanghai, China, 200123

NOT YET RECRUITING

China,

Tongji University Shanghai East Hospital

Shanghai, China,

RECRUITING

Hong Kong,

The University of Hong Kong

Hong Kong Island, Hong Kong, 999077

RECRUITING

Hong Kong,

The Chinese University of Hong Kong Prince of Wales Hospital

New Territories, Hong Kong, 999077

RECRUITING

Italy,

Polyclinic S. Orsola-Malpighi

Bologna, Italy, 40138

RECRUITING

Italy,

IRCCS Humanitas Research Hospital

Rozzano, Italy, 20089

RECRUITING

Italy,

Aoui Verona - Borgo Roma Hospital

Verona, Italy, 37134

RECRUITING

Japan, Miyagi

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

RECRUITING

Japan,

National Cancer Center Hospital East

Mr. Kashiwa, Japan, 277-0882

RECRUITING

Japan,

Nagasaki University Hospital

Mr. Nagasaki, Japan, 852-8501

RECRUITING

Japan,

Nagoya University Hospital

Mr. Nagoya, Japan, 466-8560

RECRUITING

Japan,

Osaka Metropolitan University Hospital

Long calf, Japan, 558-8585

RECRUITING

Korea, Republic of,

Inje University Hand of Hospital

Busan, Korea, Republic of, 48108

WITHDRAWN

Korea, Republic of,

Dong-A University Hospital

Busan, Korea, Republic of, 49201

RECRUITING

Korea, Republic of,

Kyungpook National University Hospital

Daegu, Korea, Republic of, 41944

RECRUITING

Korea, Republic of,

Gyeongsang National University Hospital

Cries, Korea, Republic of, 52727

RECRUITING

Korea, Republic of,

CHA BAnding Medical Center

Seongnam, Korea, Republic of, 13532

RECRUITING

Korea, Republic of,

Yonsei University Health System - Severance Hospital

Seoul, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

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

Seoul, Korea, Republic of, 06591

WITHDRAWN

Poland,

Provincial Hospital in Koszalin Nicolaus Copernicus

Koszalin, Poland, 75-581

WITHDRAWN

Poland,

Oncology Center of the Lublin Region Jan from Dukla

Lublin, Poland, 20-0920

RECRUITING

Poland,

European Centrum Zdrowia Otwock Sp. Zoo.

Otwock, Poland, 05-400

RECRUITING

Poland,

Oncology Center-Institute Maria Skłodowska - Curie

Warsaw, Poland, 02-034

RECRUITING

Portugal,

Champalimaud Foundation

Lisboa, Portugal, 1400-038

RECRUITING

Portugal,

Lisbon North Hospital Center Chln EPE - Santa Maria Hospital

Lisbon, Portugal, 1649-035

RECRUITING

Spain,

Vall d'Hebron Hospital

Barcelona, Spain, 08035

RECRUITING

Spain,

Catalan Institute of Oncology of Hospitalet de Llobregat - Hospital Duran i Reynals

Barcelona, Spain, 08908

RECRUITING

Spain,

Gregorio Maranon University General Hospital

Madrid, Spain, 28007

RECRUITING

Spain,

Clinic University of Navarra, Medical Oncology Service (Mariano Ponz Sarvise)

Madrid, Spain, 28027

RECRUITING

Spain,

Jimenez Díaz Foundation University Hospital

Madrid, Spain, 28040

RECRUITING

Spain,

October 12 University Hospital

Madrid, Spain, 28043

RECRUITING

Spain,

Clinic University of Navarra

Pamplona, Spain, 31008