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

Advanced Cholangiocarcinoma Clinical Trial

— FOENIX-CCA4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05727176
• Other study ID #: TAS-120-205
• Secondary ID: 2023-503665-3920
• Status: Recruiting
• Phase: Phase 2
• Start date: May 12, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Taiho Oncology, Inc.
• Contact: Taiho Oncology, INC
• Phone: 609-250-7336
• Email: clinicaltrialinfo[@]taihooncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cholangiocarcinoma
• Cholangiocarcinoma

Intervention

Drug:
• TAS-120
TAS-120 is an oral FGFR inhibitor

Locations

Country	Name	City	State
Argentina	CEMIC	Caba
Argentina	Hospital Britanico	Ciudad Autonoma de Buenos Aires
Argentina	Sanatorio de la Mujer	Rosario
Australia	Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center	Melbourne	Victoria
Australia	St Vincent's Hospital Sydney - The Kinghorn Cancer Centre	Sydney
Brazil	Instituto do Cancer do Estado de Sao Paulo	Cerqueira César
Brazil	Hospital Erasto Gaertner	Curitiba
Brazil	IOP - Instituto de Oncologia do Parana	Curitiba
Brazil	Hospital de Base de Sao Jose do Rio Preto	São José Do Rio Preto
Brazil	Fundacao Antonio Prudente - A.C.Camargo Cancer Center	São Paulo
China	Jilin Cancer Hospital	Changchun	Jilin
China	West China Hospital- Sichuan University	Chengdu	Sichuan
China	Guangdong Provincial People's Hospitall	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Harbin Medical University - Cancer Hospital	Harbin	Heilongjiang
China	Shandong University - Shandong Cancer Hospital	Jinan	Shandong
China	Shanghai Gobroad Cancer Hospital China Pharmaceutical University	Shanghai
Italy	Policlinico S. Orsola-Malpighi	Bologna
Italy	IRCCS Humanitas Research Hospital	Rozzano
Italy	AOUI Verona - Ospedale Borgo Roma	Verona
Japan	National Cancer Center Hospital East	Kashiwa-Shi
Japan	Nagasaki University Hospital	Nagasaki-shi
Japan	Nagoya University Hospital	Nagoya-shi
Japan	Osaka Metropolitan University Hospital	Osaka-Fu
Japan	Tohoku University Hospital	Sendai	Miyagi
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik 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	The Catholic University of Korea, St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Health System - Severance Hospital	Seoul
Poland	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 Sklodowskiej - Curie	Warszawa
Portugal	Fundação Champalimaud	Lisboa
Portugal	Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria	Lisbon
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals	Barcelona
Spain	Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario 12 de octubre	Madrid
Spain	Hospital Universitario Fundación Jimenez Díaz	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
United States	Texas Oncology	Abilene	Texas
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Center for Oncology and Blood Disorders	Houston	Texas
United States	University of California San Diego UCSD - Moores Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  China,  Italy,  Japan,  Korea, Republic of,  Poland,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	DoR by independent review	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
Secondary	PFS by independent review	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
Secondary	ORR per Investigator assessment	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
Secondary	DoR per Investigator assessment	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
Secondary	PFS per Investigator assessment	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
Secondary	OS	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
Secondary	Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0	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
Secondary	Change from Baseline in Quality of life as assessed by EORTC QLQ-C30	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
Secondary	Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D )	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