Clinical Trials /

Futibatinib in Patients With Specific FGFR Aberrations

NCT04189445

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Carcinoma
  • Lymphocytic Neoplasm
  • Malignant Solid Tumor
  • Myeloid Neoplasm
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Futibatinib in Patients With Specific FGFR Aberrations
  • Official Title: A PHASE 2 STUDY OF FUTIBATINIB IN PATIENTS WITH SPECIFIC FGFR ABERRATIONS

Clinical Trial IDs

  • ORG STUDY ID: TAS-120-202
  • SECONDARY ID: 2019-004084-49
  • NCT ID: NCT04189445

Conditions

  • Advanced or Metastatic Solid Tumor
  • Advanced or Metastatic Gastric or Gastroesophageal Cancer
  • Myeloid or Lymphoid Neoplasms (MPN)

Interventions

DrugSynonymsArms
FutibatinibTAS-120Futibatinib (Cohort A)

Purpose

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.

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 (MPN) 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
    

Trial Arms

NameTypeDescriptionInterventions
Futibatinib (Cohort A)ExperimentalAdvanced or metastatic solid tumors harboring FGFR1-4 rearrangements
  • Futibatinib
Futibatinib (Cohort B)ExperimentalAdvanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification
  • Futibatinib
Futibatinib (Cohort C)ExperimentalMyeloid or lymphoid neoplasm harboring FGFR1 rearrangement
  • Futibatinib

Eligibility Criteria

        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:

             a. Cohort A

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

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

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

        b. Cohort B

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

        ii. Measurable disease per RECIST 1.1

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

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

        c. Cohort C

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

        ii. 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:

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

               2. 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

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

          2. Prior treatment with an FGFR inhibitor

          3. Brain metastases that are untreated or clinically or radiologically unstable (that is,
             have been stable for <1 month)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) in Cohorts A and B
Time Frame:Approximately 6 months
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:ORR based on investigator assessment ORR in Cohorts A and B
Time Frame:Approximately 6 months
Safety Issue:
Description: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.
Measure:Disease control rate (DCR) in Cohort A and B
Time Frame:Approximately 6 months
Safety Issue:
Description: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), based on ICR.
Measure:Progression- free survival (PFS) in Cohorts A, B and C
Time Frame:Approximately 6 months
Safety Issue:
Description:PFS, defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on IRC), whichever occurs first
Measure:Duration of Response (DOR) in Cohorts A, B and C
Time Frame:Approximately 6 months
Safety Issue:
Description:DOR, defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first
Measure:Overall Survival (OS) in Cohorts A, B and C
Time Frame:Approximately 12 months
Safety Issue:
Description:OS, defined as the time from the date of first dose to the death date.
Measure:To assess the safety and tolerability in Cohorts A, B and C
Time Frame:Approximately 6 months
Safety Issue:
Description:Safety, based on reported AEs will be graded according to the Common Terminology Criteria for Adverse events (CTCAE), Version 5.0
Measure:To assess the safety and tolerability in Cohorts A, B and C
Time Frame:Approximately 6 months
Safety Issue:
Description:On-study laboratory parameters will be graded according to the National Cancer Institute

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Taiho Oncology, Inc.

Trial Keywords

  • Futibatinib
  • Gastric cancer
  • Gastro-esophageal junction cancer
  • Solid tumor
  • Myeloid neoplasm
  • Lymphoid neoplasm
  • FGFR
  • Amplification
  • Rearrangement
  • TAS-120

Last Updated

December 5, 2019