Advanced Cholangiocarcinoma Clinical Trial
— FOENIX-CCA4Official title:
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Taiho Oncology, Inc. |
United States, Argentina, Australia, Brazil, China, Italy, Japan, Korea, Republic of, Poland, Portugal, Spain,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05823311 -
Lenvatinib, Tislelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
|
Phase 3 | |
Not yet recruiting |
NCT06439485 -
Phase II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion
|
Phase 2 | |
Recruiting |
NCT06420349 -
NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma
|
Phase 1 | |
Recruiting |
NCT05791448 -
AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease
|
Phase 1 | |
Active, not recruiting |
NCT04093362 -
Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
|
Phase 3 | |
Recruiting |
NCT03996408 -
Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma
|
Phase 1/Phase 2 | |
Terminated |
NCT02982720 -
Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron
|
Phase 2 | |
Terminated |
NCT02150967 -
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
|
Phase 2 | |
Recruiting |
NCT03982680 -
Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma
|
Phase 2 | |
Recruiting |
NCT05532059 -
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients With Advanced Cholangiocarcinoma
|
Phase 2 | |
Terminated |
NCT04088188 -
Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma
|
Phase 1 | |
Completed |
NCT02989857 -
Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
|
Phase 3 | |
Recruiting |
NCT05805956 -
IMM2902 in Patients With Advanced Solid Tumors Expressing HER2
|
Phase 1/Phase 2 | |
Terminated |
NCT03773302 -
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
|
Phase 3 | |
Approved for marketing |
NCT04507503 -
Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
|