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Futibatinib in Patients With Specific FGFR Aberrations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04189445
Recruitment Status : Not yet recruiting
First Posted : December 6, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

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
Advanced or Metastatic Solid Tumor Advanced or Metastatic Gastric or Gastroesophageal Cancer Myeloid or Lymphoid Neoplasms (MLN) Drug: Futibatinib 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 2 STUDY OF FUTIBATINIB IN PATIENTS WITH SPECIFIC FGFR ABERRATIONS
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: TAS-120




Primary Outcome Measures :
  1. Objective response rate (ORR) in Cohorts A and B [ Time Frame: 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 [ Time Frame: 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. Objective response rate (ORR) in Cohorts A, B, and C [ Time Frame: Approximately 6 months ]
    ORR, defined as the proportion of patients experiencing a best overall response of complete response (CR) or partial response (PR) in Cohorts A and B; CR, PR, or complete response with incomplete hematological recovery (CRi) in Cohort C

  2. Duration of Response (DOR) in Cohorts A, B and C [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Approximately 6 months ]
    DCR, defined as the proportion of patients experiencing a best overall response of stable response (SD), PR, or complete response (CR).

  6. CR+CRi rate in Cohort C [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Approximately 6 months ]
    CCyR rate, defined as the proportion of patients who achieved a CCyR

  10. Partial cytogenetic response (PCyR) rate in Cohort C [ Time Frame: Approximately 6 months ]
    PCyR rate, defined as the proportion of patients who achieved a PCyR

  11. Relapse-free survival (RFS) in Cohort C [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. 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)

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): NCT04189445


Contacts
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Contact: Osamu Takahashi, MD, PhD 609-250-7336 clinicaltrialinfo@taihooncology.com

Locations
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Sponsors and Collaborators
Taiho Oncology, Inc.
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04189445    
Other Study ID Numbers: TAS-120-202
2019-004084-49 ( EudraCT Number )
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
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
Gastric cancer
Gastro-esophageal junction cancer
Solid tumor
Myeloid neoplasm
Lymphoid neoplasm
FGFR
Amplification
Rearrangement
TAS-120
Additional relevant MeSH terms:
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Neoplasms