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NCT02052778 · CITED IN SOURCE DOCUMENTS

A Study of TAS-120 in Patients With Advanced Solid Tumors

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2025-03-27

This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts: 1. Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib. 2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer. 3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD)

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outcome · POSTED

Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120

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outcome · POSTED

Phase 1: Dose Expansion: Percentage of Participants With Objective Response

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outcome · POSTED

Phase 2: Percentage of Participants With Objective Response

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outcome · POSTED

Phase 1: Dose Expansion: Duration of Response (DOR)

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outcome · POSTED

Phase 2: Duration of Response (DOR)

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outcome · POSTED

Phase 1: Dose Expansion: Disease Control Rate (DCR)

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outcome · POSTED

Phase 2: Disease Control Rate (DCR)

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outcome · POSTED

Phase 1: Dose Expansion: Progression-free Survival (PFS)

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outcome · POSTED

Phase 2: Progression-free Survival (PFS)

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outcome · POSTED

Phase 1: Dose Expansion: Overall Survival (OS)

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outcome · POSTED

Phase 2: Overall Survival (OS)

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outcome · POSTED

Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Scores at Specified Visits

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outcome · POSTED

Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits

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outcome · POSTED

Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Usual Activities Scores at Specified Visits

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outcome · POSTED

Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Pain/Discomfort Scores at Specified Visits

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outcome · POSTED

Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Anxiety/Depression Scores at Specified Visits

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outcome · POSTED

Phase 2: Change From Baseline in EQ-5D-3L Visual Analogue Scale (VAS) at Specified Visits

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outcome · POSTED

Phase 2:Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score at Specified Timepoints

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outcome · POSTED

Phase 1: Dose Expansion: Number of Participants With Any Adverse Events (AEs) and Any Serious AEs (SAEs)

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outcome · POSTED

Phase 2: Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Provide written informed consent 2. Age ≥ 18 years of age 3. Has histologically or cytologically confirmed, locally advanced or metastatic cancer 4. The following specific criteria for each study portion Phase 1 (Dose Escalation): * Patients with any type of solid tumor * Disease progression following standard therapies or intolerant to prior standard therapies Phase 1 (Dose Expansion) * Have at least one FGF/FGFR aberration * Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors). * Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or Response Assessment in Neuro-Oncology criteria (2010) for brain tumors. * Patients with any of the following tumor types * Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations * Patients with primary CNS tumors * Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations * Patients with breast cancer or gastric cancer * Patients with other solid tumor types harboring FGFR gene fusions or activating mutations * Patients with solid tumor types and other FGF/FGFR alterations not listed above Phase 2 * Patients with iCCA and FGFR2 gene rearrangements (incl fusions) * Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy * Must have documentation of radiographic progression of disease * No prior FGFR inhibitor * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Adequate organ function. Exclusion Criteria: 1. History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis. 2. History and/or current evidence of clinically significant ectopic mineralization/calcification. 3. History and/or current evidence of clinically significant retinal disorder 4. A serious illness or medical condition(s) 5. Pregnant or breast-feeding female
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants with or without fibroblast growth factor \[FGF\]/fibroblast growth factor receptor \[FGFR\] gene abnormalities received orally TAS-120 8 milligrams (mg) orally every other day (QOD; Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 8 mg
    type
    EXPERIMENTAL
  2. description
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 16 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 16 mg
    type
    EXPERIMENTAL
  3. description
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 24 mg
    type
    EXPERIMENTAL
  4. description
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 36 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 36 mg
    type
    EXPERIMENTAL
  5. description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 56 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 56 mg
    type
    EXPERIMENTAL
  6. description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 80 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 80 mg
    type
    EXPERIMENTAL
  7. description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 120 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 120 mg
    type
    EXPERIMENTAL
  8. description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 160 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 160 mg
    type
    EXPERIMENTAL
  9. description
    Participants with FGF/FGFR gene abnormalities received orally TAS-120 200 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QOD Dosing: 200 mg
    type
    EXPERIMENTAL
  10. description
    Participants with or without FGF/FGFR gene abnormalities received a dose between 4 mg orally once daily (QD) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QD Dosing: 4 mg
    type
    EXPERIMENTAL
  11. description
    Participants with or without FGF/FGFR gene abnormalities received a dose between 8 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QD Dosing: 8 mg
    type
    EXPERIMENTAL
  12. description
    Participants with or without FGF/FGFR gene abnormalities received a dose between 16 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    intervention Names
    1. Drug: Futibatinib
    label
    Phase 1: Dose Escalation: QD Dosing: 16 mg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase 1: Dose Escalation: QD Dosing: 16 mg
    2. Phase 1: Dose Escalation: QD Dosing: 20 mg
    3. Phase 1: Dose Escalation: QD Dosing: 24 mg
    4. Phase 1: Dose Escalation: QD Dosing: 4 mg
    5. Phase 1: Dose Escalation: QD Dosing: 8 mg
    6. Phase 1: Dose Escalation: QOD Dosing: 120 mg
    7. Phase 1: Dose Escalation: QOD Dosing: 16 mg
    8. Phase 1: Dose Escalation: QOD Dosing: 160 mg
    9. Phase 1: Dose Escalation: QOD Dosing: 200 mg
    10. Phase 1: Dose Escalation: QOD Dosing: 24 mg
    11. Phase 1: Dose Escalation: QOD Dosing: 36 mg
    12. Phase 1: Dose Escalation: QOD Dosing: 56 mg
    description
    oral once daily dosing, 21-day cycle
    name
    Futibatinib
    other Names
    1. TAS-120
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
407
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    MTD:Highest dose level at which \<33% of participants experience dose-limiting toxicity (DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.
    measure
    Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD)
    time Frame
    Cycle 1 (21-day cycle)
  2. description
    RP2D was MTD or less. MTD: Highest dose level at which \<33% of participants experience DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.
    measure
    Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120
    time Frame
    Cycle 1 (21-day cycle)
  3. description
    Objective response was defined as proportion of participants who had achieved best overall response of partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The CR was defined as a disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 millimeters (mm) and PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions. For Cohorts 1 to 6: Objective response was based on Independent Review Committee (IRC) and for pooled Sub-cohort: Objective response was based on investigator review.
    measure
    Phase 1: Dose Expansion: Percentage of Participants With Objective Response
    time Frame
    Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohorts
  4. description
    Objective response was defined as proportion of participants who had achieved best overall response of PR or CR per RECIST v1.1. CR was defined as a disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 mm and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. The Phase 2 evaluation of objective response was based on central independent CT/MRI image assessment.
    measure
    Phase 2: Percentage of Participants With Objective Response
    time Frame
    Up to approximately 37.5 months (through cut-off date 29-May-2021)
secondary Outcomes
  1. description
    A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. For Cohorts 1 to 6: DOR was based on IRC and for Group 3, 4, 5, 6 and for pooled Sub-cohort: DOR was based on investigator review.
    measure
    Phase 1: Dose Expansion: Duration of Response (DOR)
    time Frame
    Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohorts
  2. description
    A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. Kaplan-Meier method was used for the analysis.
    measure
    Phase 2: Duration of Response (DOR)
    time Frame
    Up to approximately 37.5 months (through cut-off date 29-May-2021)
  3. description
    A DCR was defined as the proportion of participants with objective evidence of CR, PR, or stable disease (SD), except that there was no requirement for a confirmation of an SD, if it is maintained for at least 6 weeks post treatment initiation. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes might had reduction in short axis to \<10 mm. 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. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as a reference the smallest sum diameters while on study. For Cohorts 1 to 6: DCR was based on IRC and for pooled Sub-cohort: DCR was based on investigator review.
    measure
    Phase 1: Dose Expansion: Disease Control Rate (DCR)
    time Frame
    Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohort
  4. description
    A DCR was defined as the proportion of participants with objective evidence of CR, PR, or SD, except that there was no requirement for a confirmation of an SD response, if it is maintained for at least 6 weeks post treatment initiation. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes might had reduction in short axis to \<10 mm. 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. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as a reference the smallest sum diameters while on study. DCR was based on IRC.
    measure
    Phase 2: Disease Control Rate (DCR)
    time Frame
    Up to approximately 37.5 months (through cut-off date 29-May-2021)
  5. description
    A PFS was defined as the time (in months) from the day of the first dose to the date of first documented disease progression or death (due to any cause), whichever occurred first. Participants who died without a reported disease progression were considered to have progressed on the date of their death, participants who did not progress or die were censored on the date of their last tumor assessment, participants who had no on-study assessments and did not die were censored on the first dosing date, and participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. PFS assessment per protocol was by IRC assessment for Cohorts 1 to 6 and for pooled Sub-cohort: PFS was based on investigator review.
    measure
    Phase 1: Dose Expansion: Progression-free Survival (PFS)
    time Frame
    up to approximately 27.5 months (through cut-off date 30-Jun-2019)
  6. description
    A PFS was defined as the time (in months) from the day of the first dose to the date of first objectively documented disease progression or death (any cause), whichever occurred first. Participants who had died without a reported disease progression were considered to have progressed on the date of their death, participants who did not progress or die were censored on the date of their last tumor assessment, participants who had no on-study assessments and did not die were censored on the first dosing date, and participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. PFS was analyzed as using Kaplan-Meier estimate.
    measure
    Phase 2: Progression-free Survival (PFS)
    time Frame
    Up to approximately 37.5 months (through cut-off date 29-May-2021)
  7. description
    An OS was defined as the time (in months) from the date of the first dose to the death date. In the absence of death confirmation or for participants alive as of the OS cut-off date, survival time was censored at the date of last study follow-up, or the cut-off date, whichever was earlier.
    measure
    Phase 1: Dose Expansion: Overall Survival (OS)
    time Frame
    up to approximately 27.5 months (through cut-off date 30-Jun-2019)
  8. description
    An OS was defined as the time (in months) from the date of the first dose to the death date. In the absence of death confirmation or for participants alive as of the OS cut-off date, survival time was censored at the date of last study follow-up, or the cut-off date, whichever was earlier.
    measure
    Phase 2: Overall Survival (OS)
    time Frame
    Up to approximately 37.5 months (through cut-off date 29-May-2021)
  9. description
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    measure
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Scores at Specified Visits
    time Frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
  10. description
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    measure
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits
    time Frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
  11. description
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    measure
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Usual Activities Scores at Specified Visits
    time Frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
  12. description
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    measure
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Pain/Discomfort Scores at Specified Visits
    time Frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
Full study description
brief Summary
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts: 1. Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib. 2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer. 3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
Source references
references
  1. citation
    Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klumpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Komatsu Y, Ahn DH, Epstein RS, Halim AB, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA; FOENIX-CCA2 Study Investigators. Plain language summary of the FOENIX-CCA2 study: futibatinib for people with advanced bile duct cancer. Future Oncol. 2024;20(36):2811-2822. doi: 10.1080/14796694.2024.2364504. Epub 2024 Jun 17.
    pmid
    38884254
    type
    DERIVED
  2. citation
    DiPeri TP, Zhao M, Evans KW, Varadarajan K, Moss T, Scott S, Kahle MP, Byrnes CC, Chen H, Lee SS, Halim AB, Hirai H, Wacheck V, Kwong LN, Rodon J, Javle M, Meric-Bernstam F. Convergent MAPK pathway alterations mediate acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma. J Hepatol. 2024 Feb;80(2):322-334. doi: 10.1016/j.jhep.2023.10.041. Epub 2023 Nov 14.
    pmid
    37972659
    type
    DERIVED
  3. citation
    Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klumpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Mitchell EP, Komatsu Y, Masuda K, Ahn D, Epstein RS, Halim AB, Fu Y, Salimi T, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA; FOENIX-CCA2 Study Investigators. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023 Jan 19;388(3):228-239. doi: 10.1056/NEJMoa2206834.
    pmid
    36652354
    type
    DERIVED
  4. citation
    Bahleda R, Meric-Bernstam F, Goyal L, Tran B, He Y, Yamamiya I, Benhadji KA, Matos I, Arkenau HT. Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors. Ann Oncol. 2020 Oct;31(10):1405-1412. doi: 10.1016/j.annonc.2020.06.018. Epub 2020 Jul 2.
    pmid
    32622884
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
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      requested nct id
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      primary nct id
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      payload sha256
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      id
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      link basis
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      nct id
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      occurrences
      1. context exact
        -to-head clinical trial data comparing outcomes for the various FGFR inhibitors. The multinational, open-label, single-group, phase II <a href="/clinicaltrials/NCT02052778">FOENIX-CCA2</a> trial (NCT02052778) evaluated futibatinib in patients with previously treated intrahepatic cholangiocarcinoma and <em class="gene-name">FGFR2<
        end
        140312
        exact text
        NCT02052778
        start
        140301
      2. context exact
        ng outcomes for the various FGFR inhibitors. The multinational, open-label, single-group, phase II <a href="/clinicaltrials/NCT02052778">FOENIX-CCA2</a> trial (NCT02052778) evaluated futibatinib in patients with previously treated intrahepatic cholangiocarcinoma and <em class="gene-name">FGFR2</em> fusions or rearrangements. The
        end
        140348
        exact text
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      Bile Duct Cancer (Cholangiocarcinoma) Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: March 28, 2025
        datetime
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        display
        March 28, 2025

    Preserved source evidence · Not medical advice