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Study of 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 whose cancer is either locally advanced or has spread to other parts of the body, known as metastatic cholangiocarcinoma. The treatment being tested in this trial is a medication called ivosidenib, which is taken as a film-coated tablet. Ivosidenib is designed to target specific genetic changes in the cancer cells, particularly mutations in the IDH1 gene, which are common in 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 trial will take ivosidenib orally, and the study will monitor their health and any side effects they may experience. The trial 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 specifically designed for patients with cholangiocarcinoma and gallbladder cancer.

Throughout the study, various health checks will be conducted, including blood tests, heart monitoring with an ECG (electrocardiogram), and assessments of general well-being. The trial aims to provide early access to ivosidenib for patients who have limited treatment options due to the advanced stage of their cancer. The study is expected to continue until the end of 2024, allowing researchers to gather comprehensive data on the safety and effectiveness of ivosidenib in treating this challenging form of cancer.

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, 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 orally. The dosage and frequency will be determined by the study team based on your specific condition.

    The duration of the medication administration will be outlined by the study team, and you will be monitored for any side effects or reactions.

  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 blood tests, heart monitoring, and evaluations of your cancer status.

    Your quality of life will also be assessed using questionnaires designed to understand your well-being during the study.

  5. Step 5

    End of study

    The study is expected to end by December 31, 2024. At the end of the study, your overall health and response to the medication will be evaluated.

    You will receive information about your participation and any follow-up care that may be necessary.

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, identified through a local test.
  • Have advanced or spreading CCA after receiving at least one previous treatment.
  • Have a performance status score of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Have recovered from side effects of previous cancer treatments or have them under control with medical care.
  • Have adequate bone marrow function, which means the bone marrow is working well to produce blood cells.
  • Have adequate liver function, meaning the liver is working well.
  • Have adequate kidney function, meaning the kidneys are working well.
  • Be able to understand and willing to sign the informed consent form, which is a document that explains the study and confirms your agreement to participate.
  • Agree to follow the study's guidelines on contraception, which are measures to prevent pregnancy.

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 a history of drug or alcohol abuse.
  • Patients who have had a recent major surgery.
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Investigated drugs

Ivosidenib is a medication being studied for its safety in patients who have a type of cancer called cholangiocarcinoma, which affects the bile ducts. This medication is intended for patients whose cancer has already been treated but has either returned or spread to other parts of the body. Ivosidenib works by targeting specific changes in the cancer cells that help them grow. By interfering with these changes, the medication aims to slow down or stop the growth of the cancer.

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 forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. When it is locally advanced, the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. In the metastatic stage, the cancer has spread to other parts of the body, such as the lungs or bones. The disease often progresses slowly, but it can become more aggressive over time. Symptoms may include jaundice, abdominal pain, and weight loss as the disease advances. The progression of the disease can lead to complications such as liver dysfunction and bile duct obstruction.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501463-40-00Protocol codeDIM-95031-002Estimated enrolment109 patientsSponsorServier Affaires Medicales

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