Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Stopped early · Phase 3

Conditions studied: Advanced Cholangiocarcinoma, FGFR2 Gene Rearrangements

In brief

This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements

Key facts

Study ID

NCT04093362

Run by

Taiho Oncology, Inc.

People needed

10

Starts

2021-01-06

Expected to finish

2024-04-22

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A participant must meet all of the following inclusion criteria to be eligible for enrollment in this study:
• Provide written informed consent.
• Is ≥18 years of age (or meets the country's regulatory definition for legal adult age).
• The participant has histologically confirmed, locally advanced, or metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements based on testing performed by the designated central laboratory.
• Participant has radiographically measurable disease per RECIST 1.1.
• Participants who have received treatment for locally advanced disease (for example, trans-arterial chemoembolization, selective internal radiation therapy, external beam radiation) must have evidence of radiographic progression with measurable disease outside the previously-treated lesions.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• Adequate organ function as defined by the following criteria:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 ×upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤ 5 × ULN.
• Total bilirubin ≤ 1.5 × ULN, or ≤ 3.0 × ULN for participants with Gilbert's syndrome.
• White Blood Count (WBC) ≥ 2000/mm3 (≥ 2.0 × 109/L)
• Absolute neutrophil count (ANC) ≥ 1000/mm3 (ie, ≥ 1.0 × 109/L by International Units [IU])
• Platelet count ≥ 100,000/mm3 (IU: ≥ 100 × 109/L)
• Hemoglobin ≥ 9.0 g/dL
• Phosphorus ≤ 1.5 × ULN
• Creatinine clearance: ≥ 60 mL/min
• Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to administration of the first dose of futibatinib. Female participants are not considered to be of child bearing potential if they have a history of hysterectomy or are post menopausal defined as no menses for 12 months without an alternative medical cause. Both males and females of reproductive potential must agree to use effective birth control during the study prior to the first dose and for 6 months after the last dose.
• Willing and able to comply with scheduled visits and study procedures.

You may not qualify if…

• A participant will be excluded from this study if any of the following criteria are met:
• Participant has received previous systemic anticancer therapy.
• Participants receiving adjuvant or neoadjuvant treatment and completed ≥6 months prior to randomization are eligible.
• Participant has mixed hepatocellular carcinoma - iCCA disease.
• History and/or current evidence of any of the following disorders:
• Non-tumor related alteration of calcium-phosphorus homeostasis that is clinically significant in the opinion of the Investigator.
• Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator.
• Retinal disorder confirmed by retinal examination and considered clinically significant in the opinion of the ophthalmologist.
• History or current evidence of uncontrolled ventricular arrhythmias
• Fridericia's corrected QT interval (QTcF) > 470 milliseconds (ms) on electrocardiogram (ECG) conducted during Screening.
• Treatment with any of the following within the specified time frame prior to the first dose of study therapy, or failure to recover from side effects of these prior therapies:
• Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of study therapy).
• Radiotherapy (any dose) for extended field within 4 weeks or limited field radiotherapy within 2 weeks, and/or has not recovered from acute impact of radiotherapy.
• Participants with locoregional therapy, e.g. transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks.
• Any history of liver transplant.
• A serious illness or medical condition(s) including, but not limited to, the following:
• Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month).
• Known acute systemic infection.
• Myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within the previous 6 months.
• Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the Investigator.
• Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the participant inappropriate for entry into this study.
• Participants with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention.
• Pregnant or breast-feeding female.
• The participant is unable to take oral medication.

Where it is running

• Norton Cancer Institute Audubon Hospital Campus Medical Plaza — Louisville, Kentucky, United States
• New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States
• Medical Oncology Associates, PS - Summit Cancer Centers — Spokane, Washington, United States
• Carbone Comprehensive Cancer Center — Madison, Wisconsin, United States
• Medical College of Wisconsin - Froedtert Hospital — Milwaukee, Wisconsin, United States
• Fundacion Favaloro para la Docencia e Investigacion Medica — Buenos Aires, Buenos Aires F.D., Argentina
• Hospital de Gastroenterologia Dr. C. Bonorino Udaondo — Buenos Aires, Buenos Aires F.D., Argentina
• Newcastle Private Hospital — Newcastle, New South Wales, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• UZ Antwerpen — Edegem, Antwerpen, Belgium
• Algemeen Ziekenhuis AZ Sint-Maarten — Mechelen, Antwerpen, Belgium
• AZ Delta Roeselare — Roeselare, Flanders, Belgium
• CHC MontLégia — Liège, Liege, Belgium
• IOP - Instituto de Oncologia do Parana — Curitiba, Paraná, Brazil
• Instituto Nacional de Cancer Jose Alencar Gomes da Silva - INCA — Rio de Janeiro, Rio de Janeiro, Brazil
• Instituto Americas — Rio de Janeiro, Rio de Janeiro, Brazil
• Cepho-Fm Abc — Santo André, São Paulo, Brazil
• Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto, São Paulo, Brazil
• Instituto do Cancer do Estado de Sao Paulo — São Paulo, São Paulo, Brazil
• Fundacao Antonio Prudente - A.C.Camargo Cancer Center — São Paulo, São Paulo, Brazil
• Hospital Municipal Vila Santa Catarina — São Paulo, São Paulo, Brazil
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.