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A Study of TAS-120 in Patients With Metastatic Breast Cancer

Sponsor
Taiho Oncology, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04024436
Collaborator
(none)
168
Enrollment
37
Locations
2
Arms
46
Anticipated Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a Phase 2, open-label, non-randomized, multicenter study designed to evaluate the efficacy and safety of futibatinib (TAS-120) and futibatinib + fulvestrant in up to 168 adult patients with locally advanced/metastatic breast cancer harboring FGFR gene amplifications. Patients will be enrolled to 1 of 4 treatment cohorts based on diagnosis and FGFR gene amplification status, and will receive either single agent futibatinib in Cohorts 1-3 or futibatinib plus fulvestrant in Cohort 4, as follows:

  • Cohort 1 - HR+ HER2- Measurable Disease w/ FGFR2 Amplification

  • Cohort 2 - TNBC Measurable Disease w/ FGFR2 Amplification

  • Cohort 3 - HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification

  • Cohort 4 - HR+ HER2- Measurable Disease w/ FGFR1 Amplification

Study Design

Study Type:
Interventional
Anticipated Enrollment :
168 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications
Actual Study Start Date :
Aug 30, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Futibatinib

Group/Cohort 1 Description HR+ HER2- Measurable Disease w/ FGFR2 Amplification Group/Cohort 2 Description TNBC Measurable Disease w/ FGFR2 Amplification Group/Cohort 3 Description HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification

Drug: Futibatinib
Futibatinib 20mg once daily on a 28 day cycle
Other Names:
  • TAS-120

    		•
    Experimental: Futibatinib plus Fulvestrant

    Group/Cohort 4 Description HR+ HER2- Measurable Disease w/ FGFR1 Amplification

    Drug: Futibatinib
    Futibatinib 20mg once daily on a 28 day cycle
    Other Names:
  • TAS-120

    • Drug: Futibatinib plus Fulvestrant
    Futibatinib 20mg once daily and 500 mg fulvestrant administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on a 28-day cycle.

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) - Cohorts 1, 2 [12 months (estimated)]

      Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors

    2. Clinical Benefit Rate (CBR) - Cohort 3 [12 months (estimated)]

      CBR is defined as the proportion of patients with a confirmed response of CR or SD lasting at least 24 weeks

    3. 6-month Progression-free Survival (PFS) rate - Cohort 4 [12 months (estimated)]

      The 6-month PFS rate is defined as the proportion of patients who are alive and progression-free 6 months after the first dose of study therapy

    Secondary Outcome Measures

    1. Complete Response (CR) - Cohort 3 [12 months (estimated)]

      CR is defined as the disappearance of all target and/or non-target lesions

    2. Overall Response Rate (ORR) - Cohort 4 [12 months (estimated)]

      Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors

    3. Clinical Benefit Rate (CBR) - Cohort 1,2, and 4 [12 months]

      CBR is defined as the proportion of patient with a confirmed response of CR, PR or SD lasting at least 24 weeks

    4. 6-month Progression-free Survival (PFS) rate - Cohorts 1-3 [12 months]

      6-month PFS rate is defined as the proportion of patients who are alive and progression-free 6 months after the first dose of study therapy

    5. Progression-free Survival (PFS) [12 months]

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

    6. Duration of Response (DOR) [12 months]

      DOR is defined as the time from first documentation of objective response to the date of death (any cause) or disease progression

    7. Overall Survival (OS) [12 months]

      OS is defined as the time (in months) from the first dose of study therapy to the date of death (any cause)

    8. Number of Adverse Events (AEs) Related to TAS-120 as a monotherapy and in combination with Fulvestrant [12 months]

      Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed

    9. Number of Adverse Events (AEs) Related to Futibatinib as a monotherapy and in combination with Fulvestrant [12 months]

      Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed using Common Terminology Criteria for Adverse Events (CTCAE - Version 5).

    Eligibility Criteria

    Criteria

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

    1. Provide written informed consent

    2. Age ≥ 18 years of age

    3. Histologically or cytologically confirmed recurrent locally advanced or metastatic breast cancer not amenable to treatment with curative intent, and the following cohort specific criteria:

    1. Cohort 1

    • HR+ HER2- breast cancer harboring an FGFR2 gene amplification.

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

    • Has received 1-3 prior endocrine-containing therapies and up to 2 prior chemotherapy regimens for advanced/metastatic disease

    • Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such treatment

    1. Cohort 2

    • TNBC harboring an FGFR2 gene amplification

    • Measurable disease per RECIST 1.1

    • Has received at least 1 prior chemotherapy or chemotherapy/immunotherapy (PD-L1/PD-1 inhibitors) regimen for advanced/metastatic disease C. Cohort 3

    • TNBC or HR+ HER2- breast cancer harboring an FGFR2 gene amplification

    • Non measurable, evaluable disease per RECIST 1.1. Patients with bone-only disease must have lytic or mixed lytic-blastic lesions

    • Other criteria for either HR+ HER2- breast cancer or TNBC should be met as described for Cohort 1 and 2, respectively

    1. Cohort 4

    • HR+ HER2- breast cancer harboring an FGFR1 high-level gene amplification

    • Measurable disease per RECIST 1.1

    • Has received 1-2 prior endocrine-containing therapies and no more than 1 prior chemotherapy regimen for advanced/metastatic disease. Prior treatment with fulvestrant is not permitted.

    • Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such treatment

    • Pre/peri-menopausal patients must be on goserelin

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

    2. Archival or (preferably) fresh tumor tissue must be available

    3. Adequate organ function

    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

    3. Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant

    4. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant

    5. Prior treatment with an FGFR inhibitor

    6. A serious illness or medical condition(s)

    7. Brain metastases that are untreated or clinically or radiologically unstable

    8. Pregnant or lactating female

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic - AZ Phoenix Arizona United States 85054
    2 USCF San Francisco California United States 94158
    3 Florida Cancer Specialists Fort Myers Florida United States 33901
    4 Mayo Clinic - FL Jacksonville Florida United States 32224
    5 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    6 Florida Cancer Specialists Tallahassee Florida United States 32308
    7 Florida Cancer Specialists West Palm Beach Florida United States 33401
    8 Massachusetts General Hospital Boston Massachusetts United States 02114
    9 Dana Farber Cancer Institute Boston Massachusetts United States 02115
    10 Mayo Clinic - MN Rochester Minnesota United States 55905
    11 HCA Midwest Health Kansas City Missouri United States 64132
    12 Tennessee Oncology Chattanooga Tennessee United States 37404
    13 Tennessee Oncology Nashville Tennessee United States 37203
    14 UT Southwestern Dallas Texas United States 75390
    15 MD Anderson Houston Texas United States 77030
    16 Tom Baker Cancer Center Calgary Canada T2N 4N2
    17 SunnyBrook Health Sciences Toronto Canada M4N 3M5
    18 Institut Gustave Roussy Villejuif Cedex France 94805
    19 Centre Leon Berard Lyon France 69008
    20 AOU Policlinico - Vittorio Emanuele Catania Italy 95123
    21 Istituto Europeo Di Oncologia - IEO Milano Italy 20141
    22 AOU Modena Policlinico Modena Italy
    23 Ospedale E. Agnelli Pinerolo Italy 10064
    24 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56126
    25 Istituto Nazionale Tumori Regina Elena Roma Italy 00144
    26 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy 00168
    27 Champalimaud Clinical Center Lisboa Portugal 1400-038
    28 Centro Hospitalar Universitario Lisboa Norte Lisboa Portugal 1649-035
    29 Porto University Porto Portugal 4099-001
    30 Instituto Portugues de Oncologia do Porto Porto Portugal 4200-072
    31 Vall d'Hebron Barcelona Spain 08035
    32 University Gregorio Marañon Madrid Spain 28007
    33 START Madrid - FJD Madrid Spain 28040
    34 START Madrid - CIOCC Madrid Spain 28050
    35 HCA Healthcare UK London England United Kingdom W1G 6AD
    36 The Christie NHS Foundation Trust Manchester England United Kingdom M20 4BX
    37 The Royal Marsden NHS Foundation Trust Sutton England United Kingdom SM2 5PT

    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:
    NCT04024436
    Other Study ID Numbers:
    • FOENIX-MBC2 TAS-120-201
    • 2019-001164-30
    First Posted:
    Jul 18, 2019
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 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
    Metastatic Breast Cancer
    FGFR
    TAS-120
    Additional relevant MeSH terms:
    Breast Neoplasms
    Fulvestrant
    Futibatinib

    Study Results

    No Results Posted as of May 25, 2022