Your session is about to expire
← Back to Search
IDH1 Inhibitor
AG-120 + AG-881 for Brain Tumor
Phase 1
Waitlist Available
Research Sponsored by Institut de Recherches Internationales Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have KPS of ≥60%
Have documented IDH1 R132H gene mutation by local testing and known 1p19q or ATRX mutation status by local testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks, on average
Awards & highlights
Study Summary
This trial is studying two drugs to see if they can shrink tumors in people with a certain type of brain cancer.
Who is the study for?
This trial is for adults with a confirmed diagnosis of low-grade glioma (a type of brain tumor) that has not been enhanced by previous treatments. Participants must have a specific gene mutation (IDH1 R132H), be fit for surgery but not in urgent need, and have an expected survival time of over 12 months. They should not have had radiation within the last 6 months or any prior treatment with IDH inhibitors or certain other cancer drugs.Check my eligibility
What is being tested?
The study tests AG-120 and AG-881's effectiveness at reducing levels of a substance called 2-HG in tumors from patients with IDH-1 mutant gliomas. Before surgical removal, participants will receive one of these drugs to see how well it suppresses this substance in their tumor tissue.See study design
What are the potential side effects?
While specific side effects are not listed here, similar cancer drug trials often involve risks like fatigue, nausea, headaches, skin reactions at the injection site, and potential liver toxicity. The exact side effects would be detailed during informed consent.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional assistance.
Select...
My cancer has a specific IDH1 mutation and I know my 1p19q and ATRX mutation status.
Select...
My low-grade glioma (brain tumor) is confirmed to be Grade 2 or 3.
Select...
I am 18 years old or older.
Select...
My MRI shows a non-growing tumor at least 1cm in size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 weeks, on average
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks, on average
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-HG concentration in surgically resected tumors
Secondary outcome measures
Area Under the Curve (AUC) of AG-120 or AG-881
Clinical activity associated with AG-120 or AG-881 according to modified RANO_LGG criteria.
Elimination half-life of AG-120 or AG-881
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: AG-881Experimental Treatment1 Intervention
AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-881.
Group II: AG-120Experimental Treatment1 Intervention
AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-120 .
Group III: No Treatment Pre-SurgeryActive Control1 Intervention
Subjects will not receive treatment prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-120 or AG-881.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG881
2015
Completed Phase 1
~80
AG-120
2017
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
Institut de Recherches Internationales ServierLead Sponsor
86 Previous Clinical Trials
67,087 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with an IDH inhibitor before.I can care for myself but may need occasional assistance.I am a candidate for surgery, but it's not urgent and can be scheduled within 2-4 months.I haven't taken cancer drugs or experimental treatments within the last month.I have not had radiation in the last 6 months, but I may have had a biopsy or surgery.I have previously been treated with Avastin.My cancer has a specific IDH1 mutation and I know my 1p19q and ATRX mutation status.My low-grade glioma (brain tumor) is confirmed to be Grade 2 or 3.I am 18 years old or older.My MRI shows a non-growing tumor at least 1cm in size.
Research Study Groups:
This trial has the following groups:- Group 1: AG-120
- Group 2: AG-881
- Group 3: No Treatment Pre-Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has AG881 been explored in any previous investigations?
"AG881 was first trialed in 2014 (NCT02074839) with 8 clinical trials having been completed since. Currently, 21 active studies are utilizing AG881; a sizable portion of them based in San Francisco and Massachusetts."
Answered by AI
How many medical sites are hosting this scientific research?
"This clinical trial is currently taking place in 6 distinct cities, including San Francisco, Boston and New york. To limit travel costs if you choose to join the study, it is recommended that you select a location as close to your residence as possible."
Answered by AI
Is access to participation in this research available currently?
"Data hosted on clinicaltrials.gov indicates that this medical trial is not currently recruiting patients, however it was last updated in May 16th 2022. Though the study isn't actively seeking participants at present, there are 377 other trials which are presently open to enrollment."
Answered by AI
Has AG881 been granted regulatory clearance by the FDA?
"AG881 has limited clinical evidence to support its efficacy and safety, thus receiving a score of 1 on our scale."
Answered by AI
How many participants have been accepted into this experiment?
"Unfortunately, this trial is not currently taking on new participants. It was first published in March of 2018 and its last update occurred in May 2022. For those searching for other options, there are 356 trials related to glioma recruiting patients and 21 studies actively enrolling individuals for AG881 treatment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger