Study on Futibatinib for Patients with Advanced Bile Duct Cancer with FGFR2 Gene Changes

Sponsor: Taiho Oncology, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05727176

Provider View

This clinical trial is testing the drug futibatinib to see if it is safe and effective for patients with advanced bile duct cancer (cholangiocarcinoma) that has specific FGFR2 gene changes. The study compares two different doses of the drug.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of the drug futibatinib in patients with advanced bile duct cancer (cholangiocarcinoma) that has specific changes in the FGFR2 gene. The study will compare two doses of futibatinib: 16 mg and 20 mg, taken daily in 21-day cycles. Patients will continue taking the drug until their cancer progresses or they meet other criteria for stopping treatment.

Description

This study is open to patients with advanced bile duct cancer that cannot be removed by surgery and has specific FGFR2 gene changes. Participants will be randomly assigned to one of two groups: one group will take 16 mg of futibatinib daily, and the other group will take 20 mg daily. The treatment is given in cycles of 21 days, and patients can continue as long as the treatment is effective and they do not experience unacceptable side effects. The study aims to confirm the benefits of futibatinib and determine the best dose for future research.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced or inoperable bile duct cancer (cholangiocarcinoma).
  • Cancer has specific FGFR2 gene changes.
  • Previously treated with at least one chemotherapy regimen including gemcitabine and platinum-based drugs.
  • Cancer has shown progression on the most recent treatment.
  • Have measurable cancer that can be tracked.
  • Good overall health with a performance status of 0 or 1.
  • Adequate organ function as determined by medical tests.

Exclusion Criteria

  • History or current issues with calcium and phosphate balance.
  • Significant eye disorders affecting the retina.
  • Recent major surgery or radiation therapy within specified time frames.
  • Recent treatment with other cancer therapies or investigational drugs.
  • Previous treatment with FGFR-targeted therapies.
  • Serious medical conditions such as unstable heart disease, active infections, or gastrointestinal issues affecting drug absorption.
  • Other active cancers that require treatment, unless approved by the study sponsor.
  • Pregnant or breastfeeding women.
  • Allergic reactions to futibatinib or its ingredients.

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