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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
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
Secondary ID [1] 0 0
2019-004630-42
Secondary ID [2] 0 0
TAS-120-301
Universal Trial Number (UTN)
Trial acronym
FOENIX-CCA3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cholangiocarcinoma 0 0
FGFR2 Gene Rearrangements 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
up to 12 months
Secondary outcome [1] 0 0
ORR
Timepoint [1] 0 0
up to12 months
Secondary outcome [2] 0 0
DCR
Timepoint [2] 0 0
up to 12 months
Secondary outcome [3] 0 0
OS
Timepoint [3] 0 0
up to 12 months
Secondary outcome [4] 0 0
PFS per Investigator assessment
Timepoint [4] 0 0
up to 12 months
Secondary outcome [5] 0 0
Safety and Tolerability
Timepoint [5] 0 0
up to 12 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Newcastle Private Hospital - Newcastle
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Argentina
State/province [8] 0 0
Caba
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Belgium
State/province [10] 0 0
Flemish Region
Country [11] 0 0
Belgium
State/province [11] 0 0
Liege
Country [12] 0 0
Brazil
State/province [12] 0 0
PR
Country [13] 0 0
Brazil
State/province [13] 0 0
RJ
Country [14] 0 0
Brazil
State/province [14] 0 0
SP
Country [15] 0 0
France
State/province [15] 0 0
Clichy
Country [16] 0 0
France
State/province [16] 0 0
Dijon
Country [17] 0 0
France
State/province [17] 0 0
La Tronche
Country [18] 0 0
France
State/province [18] 0 0
Lyon
Country [19] 0 0
France
State/province [19] 0 0
Montbéliard
Country [20] 0 0
France
State/province [20] 0 0
Reims
Country [21] 0 0
France
State/province [21] 0 0
Strasbourg
Country [22] 0 0
France
State/province [22] 0 0
Tours
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Mainz
Country [25] 0 0
Germany
State/province [25] 0 0
Muenchen
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Hong Kong
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Shatin
Country [28] 0 0
Italy
State/province [28] 0 0
Candiolo
Country [29] 0 0
Italy
State/province [29] 0 0
Lucca
Country [30] 0 0
Italy
State/province [30] 0 0
Monserrato
Country [31] 0 0
Italy
State/province [31] 0 0
Novara
Country [32] 0 0
Italy
State/province [32] 0 0
Parma
Country [33] 0 0
Italy
State/province [33] 0 0
Roma
Country [34] 0 0
Italy
State/province [34] 0 0
Siena
Country [35] 0 0
Italy
State/province [35] 0 0
Verona
Country [36] 0 0
Italy
State/province [36] 0 0
Vicenza
Country [37] 0 0
Japan
State/province [37] 0 0
Aichi
Country [38] 0 0
Japan
State/province [38] 0 0
Chiba
Country [39] 0 0
Japan
State/province [39] 0 0
Fukuoka
Country [40] 0 0
Japan
State/province [40] 0 0
Hokkaido
Country [41] 0 0
Japan
State/province [41] 0 0
Kanagawa
Country [42] 0 0
Japan
State/province [42] 0 0
Nagasaki
Country [43] 0 0
Japan
State/province [43] 0 0
Osaka
Country [44] 0 0
Japan
State/province [44] 0 0
Tokyo
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Jeollanam-Do
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Busan
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Daegu
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seongnam
Country [50] 0 0
Mexico
State/province [50] 0 0
Chiapas
Country [51] 0 0
Mexico
State/province [51] 0 0
MX
Country [52] 0 0
Mexico
State/province [52] 0 0
Nuevo Leon
Country [53] 0 0
Netherlands
State/province [53] 0 0
GA
Country [54] 0 0
Peru
State/province [54] 0 0
Callao
Country [55] 0 0
Peru
State/province [55] 0 0
Lima
Country [56] 0 0
Peru
State/province [56] 0 0
Arequipa
Country [57] 0 0
Poland
State/province [57] 0 0
Wielkopolskie
Country [58] 0 0
Poland
State/province [58] 0 0
Woj. Wielkopolskie
Country [59] 0 0
Portugal
State/province [59] 0 0
Lisboa
Country [60] 0 0
Portugal
State/province [60] 0 0
Porto
Country [61] 0 0
Spain
State/province [61] 0 0
Gipuzkoa
Country [62] 0 0
Spain
State/province [62] 0 0
Murcia
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Pamplona
Country [65] 0 0
Taiwan
State/province [65] 0 0
Kaohsiung
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taichung
Country [67] 0 0
Taiwan
State/province [67] 0 0
Tainan
Country [68] 0 0
Taiwan
State/province [68] 0 0
Taipei
Country [69] 0 0
Thailand
State/province [69] 0 0
Muang
Country [70] 0 0
Thailand
State/province [70] 0 0
Songkhla
Country [71] 0 0
Thailand
State/province [71] 0 0
Bangkok
Country [72] 0 0
Thailand
State/province [72] 0 0
ChiangMai
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Bristol
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Taiho Oncology, Inc.
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04093362
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries