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Study of Futibatinib for Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called advanced cholangiocarcinoma, which is a cancer that occurs in the bile ducts. The study is investigating a treatment using a medication called Futibatinib, also known by its code name TAS-120. This medication is taken as a film-coated tablet and is being tested at doses of 20 mg and 16 mg. The purpose of the study is to assess how effective Futibatinib is in providing clinical benefits to patients with this type of cancer, particularly those who have specific changes in their genes known as FGFR2 fusions or rearrangements.

Participants in the study will receive the medication orally, meaning it is taken by mouth. The study will observe how patients respond to the treatment over time, including any changes in their cancer and overall health. The trial will also monitor the safety of the medication by checking for any side effects or changes in health indicators such as laboratory test results and vital signs. The study aims to gather information on how long the treatment works, how it affects the progression of the cancer, and the overall survival of the patients.

Throughout the study, the effectiveness of the treatment will be evaluated by independent experts who will review the patients' responses. The study will also consider the patients' quality of life during the treatment, using questionnaires designed to measure their well-being. This trial is expected to continue until 2027, providing valuable insights into the potential benefits of Futibatinib for patients with advanced cholangiocarcinoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including confirmed diagnosis of advanced cholangiocarcinoma and evidence of FGFR2 gene fusions or rearrangements.

    Previous treatment with a gemcitabine and platinum-based regimen is required, along with documentation of disease progression.

  2. Step 2

    Medication administration

    The medication futibatinib is administered orally in the form of film-coated tablets.

    Dosage options include 20 mg or 16 mg taken once daily (QD).

  3. Step 3

    Monitoring and assessments

    Regular assessments are conducted to evaluate the response to treatment, including imaging studies to measure disease progression.

    The primary goal is to determine the overall response rate (ORR), which includes partial or complete response to the treatment.

  4. Step 4

    Safety evaluations

    Safety is monitored through the observation of adverse events (AEs), serious adverse events (SAEs), and any necessary dose modifications.

    Additional evaluations include clinical laboratory tests, eye exams, and monitoring of vital signs.

  5. Step 5

    Quality of life assessments

    Patient-reported outcomes (PROs) are measured using specific questionnaires to assess quality of life during the trial.

    These assessments include the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EuroQol-5D (EQ-5D).

  6. Step 6

    Trial duration

    The estimated end date for the trial is September 28, 2027.

    The recruitment for the study began on June 1, 2023.

Who can join the trial?

10 criteria

  • The patient must have **advanced cholangiocarcinoma**, which is a type of cancer that affects the bile ducts.
  • The patient must have a confirmed diagnosis of cholangiocarcinoma that is either locally advanced, metastatic (spread to other parts of the body), or cannot be removed by surgery.
  • The patient must have documented evidence of **FGFR2 gene fusions** or other **FGFR2 rearrangements**. These are specific changes in the genes that can affect cancer growth.
  • The patient must have received at least one prior treatment that included **gemcitabine** and a **platinum-based regimen**. These are types of chemotherapy drugs used to treat cancer.
  • The patient must show evidence of disease progression, meaning the cancer has gotten worse, on their most recent therapy.
  • The patient must have measurable disease according to specific guidelines called **Response Evaluation Criteria in Solid Tumors (RECIST)**.
  • The patient must have a performance status of 0 or 1 on the **Eastern Cooperative Oncology Group (ECOG) scale**, which measures how well a patient can perform daily activities.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • The study is open to both male and female patients.
  • The study includes patients who are considered part of a vulnerable population, which means they may need extra protection or care.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than advanced cholangiocarcinoma cannot participate. Cholangiocarcinoma is a type of cancer that starts in the bile ducts.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to take the study medication as required cannot participate. The medication needs to be taken in specific doses.
  • Patients who are part of a vulnerable population that the study does not include cannot participate. Vulnerable populations may include groups like pregnant women or those with certain health conditions.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria ensure the safety and effectiveness of the study.
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Investigated drugs

Futibatinib is a medication being studied for its effectiveness in treating patients with advanced cholangiocarcinoma, a type of bile duct cancer. This medication targets specific genetic changes known as FGFR2 fusions or rearrangements, which are found in some cancer cells. The trial aims to determine how well futibatinib works in managing this condition.

What is already known about the treatment

Futibatinib – Futibatinib is administered orally in tablet form, typically taken once daily. It is currently being studied in clinical trials, particularly for its effectiveness in treating advanced cholangiocarcinoma, a type of bile duct cancer, especially in patients with FGFR2 fusions or rearrangements. The medication works by inhibiting the FGFR2 protein, which is involved in cell growth and division, thereby potentially slowing down or stopping the growth of cancer cells. Futibatinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Advanced Cholangiocarcinoma – This is a type of cancer that originates in the bile ducts, which are the channels that carry bile from the liver to the small intestine. As the disease progresses, it can cause blockages in the bile ducts, leading to jaundice, abdominal pain, and liver dysfunction. The cancer cells can grow and spread to nearby tissues and organs, making it more challenging to manage. Over time, the tumor may invade blood vessels and lymph nodes, further complicating the condition. Symptoms often become more pronounced as the disease advances, affecting the patient's quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503665-39-00Protocol codeTAS-120-205Estimated enrolment120 patientsSponsorTaiho Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

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