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Futibatinib in Patients With Specific FGFR Aberrations

NCT04189445 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-10-08

Study results available
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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.

Conditions

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

Interventions

DRUG

Futibatinib

Futibatinib tablets were dosed orally every day on a continuous 28-day cycle

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2024-11-11
Completion
2024-11-11
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • Portugal
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189445 on ClinicalTrials.gov