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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04093362
Registration number
NCT04093362
Ethics application status
Date submitted
16/09/2019
Date registered
18/09/2019
Date last updated
9/01/2024
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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0
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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 - TAS-120
Treatment: Drugs - Cisplatin/Gemcitabine
Experimental: TAS-120 - TAS-120 tablets, oral; 21-day cycle
Active Comparator: Cisplatin/Gemcitabine - • On Days 1 and 8 of a 21-day cycle, patients will receive:
Cisplatin 25 mg/m2 in 1000 mL 0.9% saline by intravenous (I.V.) infusion over 1 hour, followed by 500 mL 0.9% saline over 30 minutes; and
Gemcitabine 1000 mg/m2 in 250-500 mL 0.9% saline by I.V. infusion over 30 minutes, beginning after completion of the cisplatin and saline infusions.
Treatment: Drugs: TAS-120
TAS-120 is an oral FGFR inhibitor
Treatment: Drugs: Cisplatin/Gemcitabine
Cisplatin/Gemcitabine is currently 1st line standard of care
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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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PFS: 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.
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Assessment method [1]
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Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors
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Timepoint [1]
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up to 12 months
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Secondary outcome [1]
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ORR
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Assessment method [1]
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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.
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Timepoint [1]
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up to12 months
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Secondary outcome [2]
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DCR
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Assessment method [2]
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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.
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Timepoint [2]
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up to 12 months
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Secondary outcome [3]
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OS
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Assessment method [3]
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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 12 months
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Secondary outcome [4]
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PFS per Investigator assessment
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Assessment method [4]
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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 12 months
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Secondary outcome [5]
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Safety and Tolerability
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Assessment method [5]
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Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
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Timepoint [5]
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up to 12 months
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Eligibility
Key inclusion criteria
A patient 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 patient 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. Patient has radiographically measurable disease per RECIST 1.1.
5. Patients 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 patients 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
patients 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 patient will be excluded from this study if any of the following criteria are met:
1. Patient has received previous systemic anticancer therapy.
• Patients receiving adjuvant or neoadjuvant treatment and completed =6 months prior
to randomization are eligible.
2. Patient 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 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.
- Patients 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 patient
inappropriate for entry into this study.
8. Patients 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 patient 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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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2020
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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
1/06/2024
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Actual
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Sample size
Target
216
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Accrual to date
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Final
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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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Recruitment hospital [2]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [3]
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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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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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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 patients with advanced, metastatic, or recurrent unresectable iCCA harboring
FGFR2 gene rearrangements
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04093362
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Contacts
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04093362
Download to PDF