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Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (FOENIX-CCA4)

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ClinicalTrials.gov Identifier: NCT05727176
Recruitment Status : Recruiting
First Posted : February 14, 2023
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Cholangiocarcinoma FGFR2 Fusions Gene Rearrangement Drug: TAS-120 Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Detailed Description:

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. Eligible patients will be randomized on a 1:1 basis to the following study arms:

  • Patients will receive futibatinib at an oral dose of 16 mg, administered daily (QD) on every day of a 21-day cycle.
  • Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle.

Patients may continue to receive continuous futibatinib until documentation of progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met, whichever comes first.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements
Actual Study Start Date : May 12, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm A
TAS-120 (20mg) tablets, oral; 21-day cycle
 Drug: TAS-120
TAS-120 is an oral FGFR inhibitor
Other Name: Futibatinib
Experimental: Treatment Arm B
TAS-120 (16mg) tablets, oral; 21-day cycle
 Drug: TAS-120
TAS-120 is an oral FGFR inhibitor
Other Name: Futibatinib


Outcome Measures
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Primary Outcome Measures :
  1. ORR by independent central review [ Time Frame: 12 months after the study completion ]
    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


Secondary Outcome Measures :
  1. DoR by independent review [ Time Frame: up to 12 months after the study completion ]
    defined as time from the first documentation of response to the first documentation of objective tumor progression by ICR (per RECIST 1.1) or death due to any cause, whichever occurs first

  2. PFS by independent review [ Time Frame: up to 12 months after the study completion ]
    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

  3. ORR per Investigator assessment [ Time Frame: up to 12 months after the study completion ]
    defined as proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST v1.1).

  4. DoR per Investigator assessment [ Time Frame: up to 12 months after the study completion ]
    defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first

  5. PFS per Investigator assessment [ Time Frame: up to 12 months after the study completion ]
    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

  6. OS [ Time Frame: up to 12 months after the study completion ]
    defined as the time from the date of randomization until the date of death due to any cause.

  7. Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 [ Time Frame: up to 12 months after the study completion ]
    Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0. including serious adverse events (SAEs) and dose modifications.

  8. Change from Baseline in Quality of life as assessed by EORTC QLQ-C30 [ Time Frame: up to 12 months after the study completion ]
    Change from Baseline in quality of life as assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score

  9. Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D ) [ Time Frame: up to 12 months after the study completion ]
    Change from Baseline in Quality of Life as Assessed by European Quality of Life - 5 Dimensions-3 Levels (EQ-5D-3L) Scale Score.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05727176


Contacts
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Contact: Taiho Oncology, INC 609-250-7336 clinicaltrialinfo@taihooncology.com

Locations
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Sponsors and Collaborators
Taiho Oncology, Inc.
More Information
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT05727176    
Other Study ID Numbers: TAS-120-205
2023-503665-39 ( EudraCT Number )
2022-9400 ( Other Identifier: Japan PMDA CTN Receipt Number )
First Posted: February 14, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiho Oncology, Inc.:
Futibatinib
Advanced cholangiocarcinoma
cholangiocarcinoma
FGFR2
 Fusion
Rearrangemen
TAS-120
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Futibatinib
Antineoplastic Agents