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Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) (ClarIDHy)

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Servier Protocol Code: AG120-C-005 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02989857 EudraCT Number: 2015‐005117-72

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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 49 locations

Study description

The study was done to test if ivosidenib (also called AG-120 or TIBSOVO) is an effective treatment in patients with a type of severe bile duct cancer.

Bile duct cancer (cholangiocarcinoma) is a serious and rare disease with few effective treatment options. Some cancer cells have changes called mutations in their IDH1 (isocitrate dehydrogenase 1) genes. Genes carry instructions that tell our cells how to build proteins. Cells with changes in their IDH1 genes make abnormal IDH1 proteins. The abnormal proteins make a chemical that causes cancer cells to grow and spread throughout the body. Abnormal IDH1 proteins are found in many different types of cancer.

Ivosidenib is a drug that blocks the activity of abnormal IDH1 proteins. It has already been approved in the United States to treat people who have acute myeloid leukaemia, a type of cancer in the blood and bone marrow.

The main goal of this Phase 3 study was to test how ivosidenib works compared to placebo in patients who have severe bile duct cancer with changes in the IDH1 gene. A placebo looks like the study drug but does not have any medicine in it.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Results
English (USA)
Conditions
Advanced Cholangiocarcinoma Metastatic Cholangiocarcinoma
Interventions / Treatments
  • AG-120
  • Placebo
Other study id numbers
  • AG120-C-005

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

Study participants had to:

  • Be at least 18 years old.
  • Have been diagnosed with severe bile duct cancer that could not be treated with surgery.
  • Have cancer cells with changes in the IDH1 gene.
  • Have taken 1-2 different anticancer medicines before that did not work.

Participants could not take part in the study if:

  • They had previously received a drug that blocks IDH.
  • They had received treatment with another anticancer drug or study drug less than two weeks before starting the study.
  • Their cancer had spread to the brain and required treatment with steroids (medicines to reduce swelling).

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Active Comparator: AG-120

Participants took a AG-120 500 mg tablet orally once a day, in 28-day cycles. They continued taking the treatment until their disease got worse, they experienced unacceptable side effects, they became pregnant, they passed away, they chose to stop, they couldn’t be reached, or the sponsor ended the study, for up to 45 months.

Intervention / Treatment
Drug: AG-120

Tablet taken orally

Participant Group / Arm
Placebo Comparator: Placebo

Participants took a placebo tablet that looked like AG-120 orally once a day, in 28-day cycles. They continued taking the placebo until their disease got worse, they experienced unacceptable side effects, they became pregnant, they passed away, they chose to stop, they couldn’t be reached, or the sponsor ended the study, for up to about 7 months. Those whose disease got worse while taking the placebo were allowed to switch and receive AG-120.

Intervention / Treatment
Drug: Placebo

Tablet taken orally

Participant Group / Arm
Experimental: After switch to AG-120

Participants whose disease got worse while taking the placebo were allowed to switch and receive a AG-120 500 mg tablet by mouth once a day in 28-day cycles, for up to about 32 months.

Intervention / Treatment
Drug: AG-120

Tablet taken orally

Keywords

Provided by Servier
IDH1
Additional Relevant MeSH Terms Glioma
Cholangiocarcinoma