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Study on the Long-Term Safety of Futibatinib and Fulvestrant for Patients with Malignant Solid Tumors

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What is this trial about?

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

This clinical trial focuses on patients with Malignant Solid Tumors, which are cancerous growths that can occur in various parts of the body. The study involves the use of a medication called Futibatinib, which is taken as a film-coated tablet by mouth. Some patients may also receive another medication called Fulvestrant, which is given as an injection into the muscle. The purpose of the study is to gather long-term safety information for patients who have been previously treated with Futibatinib and are continuing to benefit from it without significant risks.

Participants in this study will continue their treatment with Futibatinib alone or in combination with Fulvestrant. The study is designed to monitor the safety of these treatments over an extended period. Patients will be observed for any serious side effects or adverse events that might occur during the course of the study. The study aims to ensure that patients who are benefiting from the treatment can continue to do so safely.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, provide written informed consent to confirm understanding and agreement to participate.

    Ensure eligibility by confirming participation in a previous futibatinib study and deriving clinical benefit without undue risk.

  2. Step 2

    Initial assessments

    Women of childbearing potential must undergo a pregnancy test within 7 days before starting treatment.

    Confirm the ability to take medications orally, as the use of a feeding tube is not permitted.

  3. Step 3

    Treatment administration

    Receive futibatinib as a film-coated tablet for oral use. The dosage and frequency will be determined by the study protocol.

    If applicable, receive fulvestrant through intramuscular use, in combination with futibatinib.

  4. Step 4

    Ongoing monitoring

    Regular monitoring for any adverse events, including serious adverse events and treatment-related adverse events, will occur throughout the study.

    Report any adverse events that may lead to treatment discontinuation, graded according to the NCI-CTCAE v5.0 standards.

  5. Step 5

    End of study

    The study is estimated to conclude by April 30, 2026.

    Continue to use effective birth control during the study treatment and for a specified time after the last dose, if applicable.

Who can join the trial?

4 criteria

  • Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
  • Currently receiving a treatment called **futibatinib** either alone or with another medication called **fulvestrant** in a previous study, and benefiting from it without any significant risk, as determined by the study doctor.
  • Women who can have children must have a negative pregnancy test within 7 days before starting the study treatment. Women are not considered able to have children if they have had certain surgeries (like removal of the uterus or ovaries) or have not had a menstrual period for 12 months for reasons other than medical conditions. Both men and women who can have children must agree to use effective birth control during the study and for a certain time after the last dose of the study treatment.
  • Must be able to take medications by mouth, meaning you cannot use a feeding tube for taking the study medication.

Who cannot join the trial?

2 criteria

  • Patients who have not participated in a Taiho-sponsored Futibatinib study.
  • Patients who are not currently benefiting from the treatment with no undue risk.
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Investigated drugs

  • Futibatinib

    is a medication being studied for its long-term safety in patients who have already participated in a previous study involving this drug. It is used as a monotherapy, meaning it is given alone without any other medications, to see how well patients continue to respond to it over time.

  • Fulvestrant

    is a medication that may be combined with Futibatinib in this study. It is used to help treat certain types of cancer by blocking the effects of estrogen in the body, which can slow down or stop the growth of cancer cells. In this trial, it is used alongside Futibatinib to see if the combination provides additional benefits to patients.

What is already known about the treatment

  • Futibatinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating malignant solid tumors. It is in the investigational stage, with ongoing research to gather long-term safety data. Futibatinib works by inhibiting certain enzymes that are involved in the growth and survival of cancer cells, specifically targeting the fibroblast growth factor receptor (FGFR) pathway. It is classified as a kinase inhibitor, which is a type of targeted cancer therapy.

  • Fulvestrant

    This medication is given as an injection into the muscle and is used in combination with other treatments in clinical trials for cancer. It is an established medication in the treatment of hormone receptor-positive breast cancer. Fulvestrant works by blocking and degrading estrogen receptors, which are proteins that can promote the growth of cancer cells. It is classified as an estrogen receptor antagonist, which helps to slow down or stop the growth of cancer cells that rely on estrogen.

Investigated diseases

Malignant Solid Tumors – These are abnormal masses of tissue that arise from cells that grow uncontrollably and form a solid structure. They can occur in various parts of the body, such as the lungs, breast, prostate, or colon. As they grow, they may invade nearby tissues and organs, potentially disrupting their normal function. Over time, malignant solid tumors can spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The progression of these tumors can vary widely depending on their location, size, and the specific type of cancer cells involved. Early detection and monitoring are crucial for managing their growth and impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-512217-40-00Protocol codeTAS-120-404Estimated enrolment11 patientsSponsorTaiho Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

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