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A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

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Servier Protocol Code: CL2-95031-008 Sponsor: Servier Clinicaltrials.gov Identifier: NCT06081829

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 7 locations

Study description

This study was done to test a cancer drug called ivosidenib (also called S95031 or AG-120) in Japanese participants with a type of advanced bile duct cancer (cholangiocarcinoma). Bile ducts are tiny tubes carrying bile from the liver to the intestine. Bile helps to digest fats in food.

In several types of cancer such as cholangiocarcinoma, an abnormal form of a protein called isocitrate dehydrogenase 1 (IDH1) is present in the tumor cells due to changes called mutations. When IDH1 is mutated, it produces too much 2-hydroxyglutarate (2-HG), which is a substance that is normally present in cells at low levels. Too much 2-HG can change how normal cells function and may cause them to become tumor cells.

Ivosidenib is a drug that blocks the activity of abnormal IDH1 proteins which reduces 2-HG levels in tumor cells back to normal levels. Ivosidenib has already been approved in many countries to treat cholangiocarcinoma and certain blood cancers.

The main goal of this study was to see how well ivosidenib works in Japanese participants with advanced cholangiocarcinoma with an IDH1 mutation.

Official title: A Phase 2, Open-label, Multicenter Study of Orally Administered Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Results
English (USA)
日本語 (日本)
English (USA)
Conditions
Cholangiocarcinoma Non-resectable Cholangiocarcinoma Metastatic
Interventions / Treatments
  • Ivosidenib
Other study id numbers
  • CL2-95031-008

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be at least 18 years old.
  • Have cholangiocarcinoma:
    • with an IDH1 mutation.
    • that could not be removed by surgery (nonresectable) or had spread to other parts of the body (metastatic).
  • Have taken 1-2 different anticancer medicines before, that did not work.
  • Have good blood, kidney and liver function.

Participants could not take part in the study if:

  • They had received prior medicines that block the activity of IDH proteins.
  • Their cancer had spread to the brain, requiring treatment with steroids.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: Open-Label Ivosidenib

The study is called an “open-label” study. This means that both the participants and the research doctors knew the treatment taken.

Intervention / Treatment
Drug: Ivosidenib

Participants took ivosidenib tablets by mouth, once a day at a dose of 500 milligrams.

Keywords

Provided by Servier
IDH-1 Mutation Cholangiocarcinoma Non-resectable with an IDH-1 Mutation Cholangiocarcinoma Metastatic with an IDH-1 Mutation