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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/NCT05727176




Registration number
NCT05727176
Ethics application status
Date submitted
23/01/2023
Date registered
14/02/2023
Date last updated
22/05/2024

Titles & IDs
Public title
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
Scientific title
Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements
Secondary ID [1] 0 0
2023-503665-39
Secondary ID [2] 0 0
TAS-120-205
Universal Trial Number (UTN)
Trial acronym
FOENIX-CCA4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cholangiocarcinoma 0 0
FGFR2 Fusions 0 0
Gene Rearrangement 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - TAS-120

Experimental: Treatment Arm A - TAS-120 (20mg) tablets, oral; 21-day cycle

Experimental: Treatment Arm B - TAS-120 (16mg) tablets, oral; 21-day cycle


Treatment: Drugs: TAS-120
TAS-120 is an oral FGFR inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ORR by independent central review
Timepoint [1] 0 0
12 months after the study completion
Secondary outcome [1] 0 0
DoR by independent review
Timepoint [1] 0 0
up to 12 months after the study completion
Secondary outcome [2] 0 0
PFS by independent review
Timepoint [2] 0 0
up to 12 months after the study completion
Secondary outcome [3] 0 0
ORR per Investigator assessment
Timepoint [3] 0 0
up to 12 months after the study completion
Secondary outcome [4] 0 0
DoR per Investigator assessment
Timepoint [4] 0 0
up to 12 months after the study completion
Secondary outcome [5] 0 0
PFS per Investigator assessment
Timepoint [5] 0 0
up to 12 months after the study completion
Secondary outcome [6] 0 0
OS
Timepoint [6] 0 0
up to 12 months after the study completion
Secondary outcome [7] 0 0
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Timepoint [7] 0 0
up to 12 months after the study completion
Secondary outcome [8] 0 0
Change from Baseline in Quality of life as assessed by EORTC QLQ-C30
Timepoint [8] 0 0
up to 12 months after the study completion
Secondary outcome [9] 0 0
Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D )
Timepoint [9] 0 0
up to 12 months after the study completion

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

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center - Melbourne
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre - Sydney
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
2010 - Sydney
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
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Caba
Country [6] 0 0
Argentina
State/province [6] 0 0
Ciudad Autonoma de Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Rosario
Country [8] 0 0
Brazil
State/province [8] 0 0
Cerqueira César
Country [9] 0 0
Brazil
State/province [9] 0 0
Curitiba
Country [10] 0 0
Brazil
State/province [10] 0 0
São José Do Rio Preto
Country [11] 0 0
Brazil
State/province [11] 0 0
São Paulo
Country [12] 0 0
China
State/province [12] 0 0
Guangdong
Country [13] 0 0
China
State/province [13] 0 0
Heilongjiang
Country [14] 0 0
China
State/province [14] 0 0
Jilin
Country [15] 0 0
China
State/province [15] 0 0
Shandong
Country [16] 0 0
China
State/province [16] 0 0
Sichuan
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang
Country [18] 0 0
China
State/province [18] 0 0
Shanghai
Country [19] 0 0
Italy
State/province [19] 0 0
Bologna
Country [20] 0 0
Italy
State/province [20] 0 0
Rozzano
Country [21] 0 0
Italy
State/province [21] 0 0
Verona
Country [22] 0 0
Japan
State/province [22] 0 0
Miyagi
Country [23] 0 0
Japan
State/province [23] 0 0
Kashiwa-Shi
Country [24] 0 0
Japan
State/province [24] 0 0
Nagasaki-shi
Country [25] 0 0
Japan
State/province [25] 0 0
Nagoya-shi
Country [26] 0 0
Japan
State/province [26] 0 0
Osaka-Fu
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Busan
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Daegu
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Jinju
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seongnam
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Poland
State/province [32] 0 0
Koszalin
Country [33] 0 0
Poland
State/province [33] 0 0
Lublin
Country [34] 0 0
Poland
State/province [34] 0 0
Otwock
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Portugal
State/province [36] 0 0
Lisboa
Country [37] 0 0
Portugal
State/province [37] 0 0
Lisbon
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Pamplona

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, 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05727176
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
Taiho Oncology, INC
Address 0 0
Country 0 0
Phone 0 0
609-250-7336
Fax 0 0
Email 0 0
clinicaltrialinfo@taihooncology.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05727176