RECRUITING

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

Conditions

Advanced Cholangiocarcinoma FGFR2 Fusions Gene Rearrangement Futibatinib cholangiocarcinoma FGFR2 Fusion Rearrangemen TAS-120

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-07-05

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05727176

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Taiho Oncology, INC

CONTACT

+1 844-878-2446

medicalinformation@taihooncology.com

Study Locations (Sites)

University of California San Diego UCSD - Moores Cancer Center

La Jolla, California, 92093

United States

Tampa General Hospital Cancer Institute

Tampa, Florida, 33606

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Gabrail Cancer Center Research

Canton, Ohio, 44718

United States

Texas Oncology

Abilene, Texas, 79606-5208

United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203

United States

Center for Oncology and Blood Disorders

Houston, Texas, 77030

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2023-07-05

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-07-05

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Futibatinib
Advanced cholangiocarcinoma
cholangiocarcinoma
FGFR2
Fusion
Rearrangemen
TAS-120

Additional Relevant MeSH Terms

Advanced Cholangiocarcinoma
FGFR2 Fusions
Gene Rearrangement