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Study of AG-120 and AG-881 in Subjects With Low Grade Glioma

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Servier Protocol Code: AG120-881-C-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT03343197 EudraCT Number: 2018-001199-39

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How to participate in this 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 can’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 6 locations

Study description

This study was done to test two cancer drugs called ivosidenib (also called AG-120) and vorasidenib (also called AG-881) in patients with slow-growing brain tumors called low-grade glioma.

Glioma is a type of brain cancer that begins in ‘glial’ cells (the cells that surround and support nerve cells). It is a serious and rare disease with few effective treatment options.

In several types of cancer such as gliomas, an abnormal (mutated) form of a protein called isocitrate dehydrogenase (IDH) is present in the tumor cells due to changes called mutations. In the body, there are two types of IDH proteins: IDH1 and IDH2. When IDH1 or IDH2 is mutated, it produces too much 2-hydroxyglutarate (2-HG), which is a substance that is normally present in cells at low levels. When there is too much 2-HG, it impairs normal cell functioning and may cause the cells to become tumor cells.

Vorasidenib blocks the activity of abnormal IDH1 and IDH2 proteins. Ivosidenib blocks the activity of abnormal IDH1 protein. Vorasidenib and ivosidenib may reduce 2-HG levels in tumor cells back to normal levels.

The main objective of this study was to measure the level of 2-HG in surgically removed tumors after being treated with ivosidenib or vorasidenib compared with untreated (no treatment) tumors.

Official title: A Phase 1, Multicenter, Randomized, Controlled, Open-Label, Perioperative Study of AG-120 and AG-881 in Subjects With Recurrent, Non-Enhancing, IDH1 Mutant, Low Grade Glioma
Results
English (USA)
English (USA)
Conditions
Glioma
Interventions / Treatments
  • AG-120
  • AG881
Other study id numbers
  • AG120-881-C-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be at least 18 years old.
  • Have low grade glioma:
    • with a specific type of IDH1 mutation.
    • that can be removed with surgery in the next 2 to 4 months.
  • Have good blood, kidney, and liver function.

Participants were not included in the study if they:

  • Had already taken medicines that block the activity of IDH proteins.
  • Had radiation therapy within 6 months before starting the study.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
No Intervention: No Treatment

Before surgery, participants received no treatment for at least 28 days, including the day of the surgery.

Intervention / Treatment
Participant Group / Arm
Experimental: Ivosidenib

Before surgery, participants received treatment with ivosidenib for at least 28 days, including the day of surgery.

Intervention / Treatment
Drug: Ivosidenib

Participants took ivosidenib tablets by mouth at 250 mg twice daily or 500 mg once daily.

Participant Group / Arm
Experimental: Vorasidenib

Before surgery, participants received treatment with vorasidenib for at least 28 days, including the day of surgery.

Intervention / Treatment
Drug: Vorasidenib

Participants took 10 mg or 50 mg vorasidenib tablets by mouth once daily.

Keywords

Provided by Servier
Glioma IDH1 AG-120 AG-881
Additional Relevant MeSH Terms Glioma
Glioma