Futibatinib in Patients With Specific FGFR Aberrations

  • STATUS
    Recruiting
  • End date
    Oct 7, 2022
  • participants needed
    115
  • sponsor
    Taiho Oncology, Inc.
Updated on 7 October 2021

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.

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.

Details
Condition Advanced or Metastatic Solid Tumor, Advanced or Metastatic Gastric or Gastroesophageal Cancer, Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN), Myeloid or Lymphoid Neoplasms (MLN)
Treatment Futibatinib
Clinical Study IdentifierNCT04189445
SponsorTaiho Oncology, Inc.
Last Modified on7 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts
Cohort A
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

History and/or current evidence of any of the following disorders
Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator
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
Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator
Prior treatment with an FGFR inhibitor
Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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