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Study on Ivosidenib for Patients with Previously Treated Advanced or Metastatic Cholangiocarcinoma

Verified siteRegistered drugNo 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 cholangiocarcinoma, which affects the bile ducts. The study is specifically for patients who have locally advanced or metastatic cholangiocarcinoma, meaning the cancer has spread and cannot be removed by surgery. The treatment being tested is a medication called ivosidenib, which is taken as a film-coated tablet. Ivosidenib is designed to target a specific genetic mutation known as IDH1 that is found in some patients with this type of cancer.

The purpose of the study is to evaluate the safety of ivosidenib in patients who have already received other treatments for their cancer. Participants in the study will receive ivosidenib and will be monitored for any side effects or changes in their health. The study will also look at how the cancer responds to the treatment, including how long patients live without the cancer getting worse and their overall survival. Additionally, the study will assess the quality of life of participants using a questionnaire designed for patients with cholangiocarcinoma.

Throughout the study, participants will have regular check-ups, which may include blood tests, heart monitoring with an ECG (a test that records the electrical activity of the heart), and assessments of their general health and well-being. The study aims to provide early access to ivosidenib for patients who have limited treatment options and to gather important information about its effects in this group of patients.

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

    Upon joining the study, you will be required to sign an informed consent form. This form confirms that you understand the study procedures and agree to participate.

    You must be at least 18 years old and have a diagnosis of locally advanced or metastatic cholangiocarcinoma, which is a type of cancer that affects the bile ducts.

  2. Step 2

    Eligibility confirmation

    Your eligibility will be confirmed based on specific criteria, including having a certain gene mutation and having received at least one prior line of systemic therapy.

    Your overall health will be assessed, including bone marrow, liver, and kidney function, to ensure you meet the study requirements.

  3. Step 3

    Medication administration

    You will receive the medication ivosidenib, which is taken orally. The dosage and frequency will be determined by the study team and will be explained to you in detail.

    The duration of the medication administration will be specified by the study protocol, and you will be monitored regularly to assess your response to the treatment.

  4. Step 4

    Regular assessments

    Throughout the study, you will undergo regular assessments to monitor your health and the effects of the medication. This includes safety laboratory tests, electrocardiograms (ECG), and checks of vital signs.

    Your performance status, which measures your ability to carry out daily activities, will also be evaluated.

  5. Step 5

    Response evaluation

    The study will evaluate your response to the treatment based on tumor assessments. This will help determine the progression-free survival, overall survival, and duration of response.

    Your quality of life will be assessed using a questionnaire specifically designed for patients with cholangiocarcinoma and gallbladder cancer.

  6. Step 6

    Study completion

    The study is expected to continue until December 31, 2024. Your participation may end earlier if you experience significant side effects or if the study team decides it is in your best interest.

    Upon completion, you will have a final assessment to review your health status and any effects of the treatment.

Who can join the trial?

11 criteria

  • Be at least 18 years old.
  • Have a confirmed diagnosis of cholangiocarcinoma (CCA) that cannot be removed by surgery or treated with a liver transplant or other local treatments.
  • Have a specific genetic change in the IDH1 gene (R132C, R132L, R132G, R132H, or R132S) confirmed by a local test.
  • Have advanced or spreading CCA after receiving at least one previous treatment.
  • Have an ECOG Performance Status score of 0 or 1, which means you are fully active or have some symptoms but can still do light work. The ECOG Performance Status is a scale used to assess how a disease affects a patient's daily living abilities.
  • Have recovered from side effects of previous cancer treatments or have them under control with medical care.
  • Have adequate bone marrow function, which means your bone marrow is working well enough to produce blood cells.
  • Have adequate liver function, meaning your liver is working well enough as described in the study protocol.
  • Have adequate kidney function, meaning your kidneys are working well enough as described in the study protocol.
  • Be able to understand and willing to sign the informed consent form and follow the study procedures. The informed consent form is a document that explains the study and what is expected from participants.
  • Agree to follow the study's guidelines on contraception, which means using birth control methods to prevent pregnancy during the study.

Who cannot join the trial?

10 criteria

  • Patients who have not been previously treated for their condition.
  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients who have allergies to the study medication or similar drugs.
  • Patients who are participating in another clinical trial.
  • Patients with a history of certain heart conditions.
  • Patients with uncontrolled infections.
  • Patients with severe liver or kidney problems.
  • Patients who have had a recent surgery.
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Investigated drugs

Ivosidenib is a medication used in this clinical trial to help treat patients with a specific type of cancer called cholangiocarcinoma, which affects the bile ducts. This medication works by targeting and blocking a certain protein that is involved in the growth of cancer cells. By doing this, it may help slow down or stop the progression of the cancer. The trial is focused on understanding how safe this medication is for patients who have already received other treatments for their advanced or metastatic cholangiocarcinoma.

What is already known about the treatment

Ivosidenib – Ivosidenib is administered orally in the form of tablets. It is currently being studied in clinical trials for its safety and effectiveness in treating patients with locally advanced or metastatic cholangiocarcinoma, a type of bile duct cancer. The main therapeutic indication for ivosidenib is for patients who have already received other treatments for this condition. At the molecular level, ivosidenib works by inhibiting a specific enzyme called IDH1, which is involved in the growth of cancer cells. It is classified pharmacologically as an IDH1 inhibitor.

Investigated diseases

Locally Advanced or Metastatic Cholangiocarcinoma – Cholangiocarcinoma is a type of cancer that originates in the bile ducts, which are small tubes that carry bile from the liver to the small intestine. When it is described as locally advanced, it means the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. Metastatic cholangiocarcinoma indicates that the cancer has spread to distant organs or tissues. The disease often progresses by invading surrounding structures and can lead to blockages in the bile ducts. As it advances, symptoms such as jaundice, abdominal pain, and weight loss may occur. The progression of the disease can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501463-40-01Protocol codeDIM-95031-002Estimated enrolment280 patientsSponsorServier Affaires Medicales

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