Study of Vorasidenib for Patients with Residual or Recurrent Grade 2 Glioma with IDH1 or IDH2 Mutation

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What is this study about?

This clinical trial is focused on studying a type of brain tumor called Grade 2 glioma, which can either be residual or come back after treatment. These tumors have specific changes in their genes known as IDH1 or IDH2 mutations. The study is testing a new treatment called vorasidenib, also known by its code name S95032/AG-881. This medication is taken as a tablet by mouth and is being compared to a placebo to see how well it works in treating this type of glioma.

The purpose of the study is to see if vorasidenib can help slow down the growth of the tumor when compared to a placebo. Participants in the study will be randomly assigned to receive either the vorasidenib tablets or placebo tablets. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, which is known as a double-blind study. The treatment period can last up to 96 weeks, and participants will have regular check-ups and imaging tests like MRI to monitor the tumor’s response to the treatment.

Throughout the study, the safety of vorasidenib will be closely monitored by checking for any side effects or changes in health. Participants will also have their blood tested to understand how the body processes the medication. The study aims to provide valuable information on whether vorasidenib can be an effective treatment option for people with Grade 2 glioma with IDH1 or IDH2 mutations.

1 randomization

Upon joining the study, participants are randomly assigned to receive either the study drug vorasidenib or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

2 medication administration

Participants take the assigned medication orally. The study drug, vorasidenib, is provided in the form of film-coated tablets. The dosage and frequency of administration are determined by the study protocol and communicated to participants by the study team.

3 regular assessments

Participants undergo regular assessments to monitor the effectiveness and safety of the treatment. These assessments include imaging tests to evaluate the progression of the glioma, as well as blood tests to measure the concentration of the drug and its metabolites in the body.

4 safety monitoring

Throughout the study, participants are monitored for any adverse effects. This includes regular checks of vital signs, heart function through electrocardiograms (ECGs), and overall health status using performance scales.

5 study completion

The study is expected to continue until May 2028. Upon completion, participants may undergo final assessments to evaluate the long-term effects of the treatment.

Who Can Join the Study?

Be at least 12 years old and weigh at least 40 kilograms.
Have a type of brain tumor called Grade 2 oligodendroglioma or astrocytoma according to the WHO 2016 criteria.
Have had at least one previous surgery for the brain tumor, with the last surgery being at least 1 year ago but not more than 5 years ago. No other cancer treatments like chemotherapy or radiotherapy should have been received, and there should be no immediate need for these treatments according to the doctor’s opinion.
Have a confirmed IDH1 or IDH2 gene mutation in the tumor, which is a specific change in the genes, confirmed by a central laboratory test. Also, have available information on 1p19q status, which is another genetic detail, tested by an accredited laboratory.
Have a brain tumor that can be measured by an MRI scan, which is a type of imaging test, and the tumor should not be enhancing, as confirmed by a special review committee.
Have a KPS score of 80% or higher if 16 years or older, or an LPPS score of 80% or higher if younger than 16 years. These scores measure the ability to perform daily activities.

Who Cannot Join the Study?

Patients who have not had surgery as their only treatment for their brain tumor.
Patients who do not have a specific type of brain tumor called Grade 2 glioma with an IDH1 or IDH2 mutation. These are specific changes in the genes of the tumor cells.
Patients who have a different type of brain tumor than oligodendroglioma or astrocytoma. These are specific types of brain tumors.
Patients who are not within the age range specified for the study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Ugobzhdxwk Mccvnce Cisjlx Hdjsewuazpkplqhnt	Hamburg	Germany
Uadefbisxicowrckbcpmx Eibru Aed	Essen	Germany
Ayzlsyjald Pymcgyow Hcsvckzj Dm Mkedmxvbm	Marseille	France
Evtbmee Uaqbcqolsrld Mwprfkp Clvapkp Rukadlgoo (ulehvrd Myk	Rotterdam	The Netherlands
Aksoomo Oodqpjnukqw Uwxbanaoepejs Cqtinoskyfbx Dzrog Sxzfrs E Dtgdi Swrxbeq Dy Tmxalu	Turin	Italy
Hpvdohyy Vdyh depjsywy	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	21.02.2020
Germany	Not recruiting	21.02.2020
Italy	Not recruiting	21.02.2020
Spain	Not recruiting	21.02.2020
The Netherlands	Not recruiting	21.02.2020

Trial locations

Investigated drugs:

Vorasidenib

Vorasidenib is a medication being studied for its effectiveness in treating certain types of brain tumors called oligodendroglioma and astrocytoma. These tumors have specific genetic changes known as IDH1 or IDH2 mutations. Vorasidenib is being tested to see if it can help slow down the growth of these tumors in patients who have already had surgery.

Investigated diseases:

Glioma

Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation – This is a type of brain tumor that arises from glial cells, which support and protect nerve cells in the brain. It is characterized by a mutation in the IDH1 or IDH2 genes, which are involved in cellular metabolism. These tumors are classified as Grade 2, indicating they are low-grade and grow more slowly than higher-grade gliomas. Despite their slower growth, they can still infiltrate surrounding brain tissue, making them challenging to completely remove surgically. Over time, these gliomas may recur or persist even after initial treatment, such as surgery. The presence of the IDH mutation can influence the behavior and progression of the tumor.

Trial ID:

2024-512961-15-00

Protocol code:

AG881-C-004

NCT ID:

NCT04164901

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Vorasidenib for Patients with Residual or Recurrent Grade 2 Glioma with IDH1 or IDH2 Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?