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Futibatinib in Patients With Specific FGFR Aberrations

Sponsor
Taiho Oncology, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04189445
Collaborator
(none)
115
Enrollment
61
Locations
3
Arms
27.2
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on diagnosis and FGFR gene aberration status.

Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle.

The study will enroll approximately:

  • Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor harboring FGFR rearrangements other than primary brain tumor or iCCA;

  • Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer or gastro-esophageal junction (GEJ) with FGFR2 amplification;

  • Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1 rearrangements

Treatment in all cohorts will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met. For patients who discontinue treatment for reasons other than disease progression, tumor assessments should be continued until radiologic disease progression is documented or until initiation of subsequent new anticancer therapy (whichever occurs first).

Patients will be followed for survival every 12 weeks (±2 weeks) until survival events (deaths) have been reported for 75% of enrolled patients or the study is terminated early by the Sponsor.

Additional cohorts may be added in the future in case of new emerging efficacy data.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
115 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study consists of independent 3 cohorts (Cohorts A, B and C) and there is no difference in the treatment regimen between the cohortsThe study consists of independent 3 cohorts (Cohorts A, B and C) and there is no difference in the treatment regimen between the cohorts
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations
Actual Study Start Date :
Aug 24, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Futibatinib (Cohort A)

Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements

Drug: Futibatinib
Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle
Other Names:
  • TAS-120

    		•
    Experimental: Futibatinib (Cohort B)

    Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification

    Drug: Futibatinib
    Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle
    Other Names:
  • TAS-120

    		•
    Experimental: Futibatinib (Cohort C)

    Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement

    Drug: Futibatinib
    Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle
    Other Names:
  • TAS-120

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) in Cohorts A and B [Approximately 6 months]

      ORR, defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on independent central review of radiological images.

    2. Complete response (CR) rate in Cohort C [Approximately 6 months]

      CR rate, defined as the proportion of patients who achieved a CR (per response criteria for MLN) based on investigators' assessment of imaging, peripheral blood, and bone marrow.

    Secondary Outcome Measures

    1. ORR based on investigator assessment ORR in Cohorts A and B [Approximately 6 months]

      ORR, 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 investigator assessment.

    2. Duration of Response (DOR) in Cohorts A, B and C [Approximately 6 months]

      DOR, defined as the time from the first documentation of response (CR or PR in Cohorts A and B; CR, PR, or CRi in Cohort C) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.

    3. Progression- free survival (PFS) in Cohorts A, B and C [Approximately 6 months]

      PFS, defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression, whichever occurs first.

    4. Overall Survival (OS) in Cohorts A, B and C [Approximately 12 months]

      OS, defined as the time from the date of first dose to the death date.

    5. Disease control rate (DCR) in Cohort A and B [Approximately 6 months]

      DCR, defined as the proportion of patients experiencing a best overall response of stable response (SD), PR, or complete response (CR) (per RECIST 1.1).

    6. CR+CRi rate in Cohort C [Approximately 6 months]

      CR+CRi rate, defined as the proportion of patients who achieved a CR or CRi

    7. Duration of CR in Cohort C [Approximately 6 months]

      Duration of CR, defined as the time from the first documentation of CR to the first documentation of recurrence or death due to any cause, whichever occurs first.

    8. Duration of CR+CRi in Cohort C [Approximately 6 months]

      Duration of CR+CRi, defined as the time from the first documentation of CR or CRi to the first documentation of disease relapse or death due to any cause, whichever occurs first.

    9. Complete cytogenetic response (CCyR) rate in Cohort C. [Approximately 6 months]

      CCyR rate, defined as the proportion of patients who achieved a CCyR

    10. Partial cytogenetic response (PCyR) rate in Cohort C [Approximately 6 months]

      PCyR rate, defined as the proportion of patients who achieved a PCyR

    11. Relapse-free survival (RFS) in Cohort C [Approximately 6 months]

      RFS, defined as the time from first documentation of CR to the date of death (any cause) or disease relapse or death due to any cause, whichever occurs first

    12. Event-free survival (EFS) in Cohort C [Approximately 6 months]

      EFS, defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or patient death due to any cause, whichever occurs first

    13. To assess the safety and tolerability in Cohorts A, B and C [Approximately 6 months]

      Safety based on reported AEs will be graded according to the National Cancer Institute- Common Terminology Criteria for Adverse events (NCI-CTCAE), Version 5.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    2. Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:

    1. Cohort A

    2. Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4

    1. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    2. Had disease progression/recurrence after standard treatment for their cancer

    1. Cohort B

    2. Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification.

    1. Measurable disease per RECIST 1.1

    2. Received at least 2 prior systemic regimens for advanced/metastatic disease

    3. Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer

    1. Cohort C

    2. Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1 rearrangement

    1. Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies
    Exclusion Criteria:

    1. History and/or current evidence of any of the following disorders:

    2. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator

    3. 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

    4. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator.

    5. Prior treatment with an FGFR inhibitor

    6. Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234-2165
    2 UCLA Medical Center Los Angeles California United States 90404
    3 Georgetown University - Lombardi Comprehensive Cancer Center Washington District of Columbia United States 20007
    4 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    5 University of Maryland Baltimore Maryland United States 21201
    6 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215-5400
    7 Henry Ford Hospital Woodhaven Michigan United States 48183
    8 Mercy Clinic Oncology and Hematology - Coletta Oklahoma City Oklahoma United States 73120
    9 Fox Chase Cancer Center Philadelphia Pennsylvania United States 53705
    10 Houston Methodist Cancer Center Houston Texas United States 77030
    11 The University of Texas M. D. Anderson Cancer Center Houston Texas United States 77030
    12 Institut Jules Bordet Bruxelles Belgium 1000
    13 Centre Antoine Lacassagne Nice Alpes Maritimes France 06200
    14 Centre Paul Strauss Strasbourg Bas Rhin France 67000
    15 Centre Georges François Leclerc Dijon Côte-d'Or France 21079
    16 Institut Bergonié Bordeaux Gironde France 33076
    17 Hôpital Saint-Louis Paris Cedex 10 Paris France 75475
    18 Centre Léon Bérard Lyon Rhone France 69008
    19 Centre Hospitalier Lyon Sud Pierre Benite cedex Rhone France 69495
    20 Institut Gustave Roussy Villejuif Val De Marne France 94805
    21 Universitaetsklinikum Freiburg Freiburg Baden Wuerttemberg Germany 79106
    22 Universitaetsklinikum Heidelberg Heidelberg Baden Wuerttemberg Germany 69120
    23 Universitaetsklinikum Koeln Koeln Nordrhein Westfalen Germany 50924
    24 The University of Hong Kong Hong Kong Hong Kong
    25 Hong Kong United Oncology Centre Jordon Hong Kong 0000
    26 Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori Meldola Forli - Cesena Italy 47014
    27 Ospedale Sacro Cuore Don Calabria Negrar Verona Italy 37024
    28 Azienda Ospedaliera Universitaria Careggi Florence Italy 50134
    29 IEO Istituto Europeo di Oncologia Milano Italy 20141
    30 Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento) Verona Italy 37124
    31 Aichi Cancer Center Hospital Nagoya-shi Aichi-Ken Japan 464-8681
    32 National Cancer Center Hospital East Kashiwa-shi Chiba-Ken Japan 277-8577
    33 NHO Shikoku Cancer Center Matsuyama-shi Ehime-Ken Japan 791-0280
    34 Hokkaido University Hospital Sapporo-shi Hokkaido Japan 060-8648
    35 Osaka University Hospital Suita-shi Osaka-Fu Japan 565-0871
    36 National Cancer Center Hospital Chuo-ku Tokyo-To Japan 104-0045
    37 Seoul National University Bundang Hospital Seongnam Gyeonggi-do Korea, Republic of 13620
    38 Asan Medical Center Seoul Korea, Republic of 05505
    39 Seoul National University Hospital Seul Korea, Republic of 03080
    40 Severance Hospital, Yonsei University Health System Seul Korea, Republic of 03722
    41 Samsung Medical Center Seul Korea, Republic of 06351
    42 Antoni van Leeuwenhoek Amsterdam Netherlands 1066 CX
    43 Erasmus Medisch Centrum Rotterdam Netherlands 3015 AA
    44 Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos Lisboa Portugal 1169-050
    45 Fundação Champalimaud Lisboa Portugal 4099-001
    46 Centro Hospitalar do Porto, E.P.E - Hospital de Santo Antonio Porto Portugal 4099-001
    47 National University Cancer Institute Singapore Singapore 119074
    48 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    49 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    50 Hospital Universitario HM Madrid Sanchinarro Madrid Spain 28050
    51 Clinica Universidad de Navarra Pamplona Spain 31008
    52 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    53 Instituto Valenciano de Oncologia IVO Valencia Spain 46009
    54 Hospital Clinico Universitario de Valencia Valencia Spain 46010
    55 Hospital Universitari i Politecnic La Fe Valencia Spain 46026
    56 Karolinska universitetssjukhuset - Solna Solna Sweden 171 64
    57 Akademiska Sjukhuset Uppsala Sweden 75185
    58 Acibadem Adana Hospital Adana Turkey 01130
    59 Acibadem Maslak Hospital Istanbul Turkey 34457
    60 Namik Kemal University Tekirdağ Turkey 59100
    61 Sarah Cannon Research Institute UK London Greater London United Kingdom W1G 6AD

    Sponsors and Collaborators

    • Taiho Oncology, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taiho Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT04189445
    Other Study ID Numbers:
    • TAS-120-202
    • 2019-004084-49
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Gastric cancer
    Gastro-esophageal junction cancer
    Solid tumor
    Myeloid neoplasm
    Lymphoid neoplasm
    FGFR
    Amplification
    Rearrangement
    TAS-120
    Additional relevant MeSH terms:
    Neoplasms
    Futibatinib

    Study Results

    No Results Posted as of Jul 5, 2022