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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
University Hospital Maastricht Maastricht The Netherlands
Medizinische Universitaet Innsbruck Innsbruck Austria
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Charite Research Organisation GmbH Berlin Germany
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Axouorwjm Ucu Amsterdam The Netherlands
Umhgtsclkqyxoqqlbgchf Dudngepswol Awh Duesseldorf Germany
Melvblt Uboncswwnm Od Gvxq Graz Austria
Ejezjkr Udxjkkpvxgps Mlawesh Crmyxgu Rcbopawfh (bcltaow Mho Rotterdam The Netherlands
Gmiwun Ucojqaoymy Fuisrxmsg Frankfurt Germany
Sbocqqwjrvc Uxauejgvoy Hxedkkbyzplsacj Gxfbxzobbojbxkcja Gothenburg Sweden
Kqxuehog dur Ufqvcavzknyt Myjyktdz Afb Munich Germany
Oiixmujdiuvjwr Ludk Gado Linz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
30.01.2023
Germany Germany
Not yet recruiting
30.01.2023
Sweden Sweden
Not yet recruiting
30.01.2023
The Netherlands The Netherlands
Not yet recruiting
30.01.2023

Trial locations

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.

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 ID:
2022-501463-40-00
Protocol code:
DIM-95031-002
Trial Phase:
Therapeutic confirmatory (Phase III)

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