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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04093362
Registration number
NCT04093362
Ethics application status
Date submitted
16/09/2019
Date registered
18/09/2019
Date last updated
25/03/2025
Titles & IDs
Public title
Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
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Scientific title
A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3
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Secondary ID [1]
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2019-004630-42
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Secondary ID [2]
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TAS-120-301
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Universal Trial Number (UTN)
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Trial acronym
FOENIX-CCA3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cholangiocarcinoma
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FGFR2 Gene Rearrangements
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Condition category
Condition code
Cancer
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Futibatinib
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Experimental: Futibatinib - Participants received futibatinib at an oral dose of 20 milligrams (mg), administered once daily (QD) on every day of a 21-day cycle up to disease progression.
Active comparator: Cisplatin/Gemcitabine - Participants received cisplatin 25 milligrams per square meter (mg/m\^2) IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle up to 8 cycles.
Treatment: Drugs: Futibatinib
Oral tablets
Treatment: Drugs: Cisplatin
IV infusion
Treatment: Drugs: Gemcitabine
IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time from date of randomization to the date of documentation of disease progression by independent central review (ICR), or date of death, whichever occurs first. Response assessments were made based on Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
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Timepoint [1]
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Up to approximately 28 months
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR was defined as the proportion of participants experiencing a best overall response of partial response (PR) or complete response (CR) as per RECIST 1.1, based on ICR. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to less than (\<)10 millimeters (mm) and disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10-mm short axis)
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Timepoint [1]
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Up to approximately 28 months
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Secondary outcome [2]
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Disease Control Rate (DCR)
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Assessment method [2]
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DCR was defined as the proportion of participants experiencing a best overall response of stable disease (SD), PR or CR as per RECIST 1.1, based on central assessment of radiologic images. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm and disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10-mm short axis).
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Timepoint [2]
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Up to approximately 28 months
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS was defined as the time from the date of randomization until the date of death due to any cause.
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Timepoint [3]
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Up to approximately 28 months
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Secondary outcome [4]
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Progression-Free Survival (PFS) Per Investigator Assessment
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Assessment method [4]
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PFS per investigator assessment is 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.
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Timepoint [4]
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Up to approximately 28 months
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Secondary outcome [5]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
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Assessment method [5]
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An adverse event (AE) was defined as any untoward medical condition in clinical investigation participant administered drug; it does not necessarily have to have causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after first dose of study drug administration and within 30 days after last dose of study drug and does not necessarily have a causal relationship to use of the study drug. TEAEs were assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). SAE was any untoward medical occurrence that at any dose: results in death, is life-threatening, required in participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, important medical event. TEAEs included any clinically significant changes in clinical laboratory tests, vital signs, ophthalmological exams, and 12-lead electrocardiogram (ECG).
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Timepoint [5]
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Up to approximately 28 months
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Eligibility
Key inclusion criteria
A participant must meet all of the following inclusion criteria to be eligible for enrollment in this study:
1. Provide written informed consent.
2. Is =18 years of age (or meets the country's regulatory definition for legal adult age).
3. 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.
4. Participant has radiographically measurable disease per RECIST 1.1.
5. 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.
6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
7. 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
8. 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.
9. Willing and able to comply with scheduled visits and study procedures.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
A participant will be excluded from this study if any of the following criteria are met:
1. Participant has received previous systemic anticancer therapy.
•Participants receiving adjuvant or neoadjuvant treatment and completed =6 months prior to randomization are eligible.
2. Participant has mixed hepatocellular carcinoma - iCCA disease.
3. 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.
4. History or current evidence of uncontrolled ventricular arrhythmias
5. Fridericia's corrected QT interval (QTcF) > 470 milliseconds (ms) on electrocardiogram (ECG) conducted during Screening.
6. 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.
7. 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.
8. Participants with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention.
9. Pregnant or breast-feeding female.
10. The participant is unable to take oral medication.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/04/2024
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Newcastle Private Hospital - Newcastle
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Flinders Medical Centre - Bedford Park
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Peter MacCallum Cancer Centre - Melbourne
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2305 - Newcastle
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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3002 - Melbourne
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
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Name
Taiho Oncology, Inc.
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Ethics approval
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Summary
Brief summary
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
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Trial website
https://clinicaltrials.gov/study/NCT04093362
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Trial related presentations / publications
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Contacts
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/62/NCT04093362/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/62/NCT04093362/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04093362
Download to PDF