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IDH Inhibitor
AG-881 for Brain Tumor
Phase 1
Waitlist Available
Research Sponsored by Agios Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks, on average
Awards & highlights
Summary
This trial is testing a new drug for patients with brain tumors that have a specific genetic mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 26 weeks, on average
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 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
Maximum Tolerated Dose and/or the recommended Phase II dose of AG881 in patients with advance solid tumors, including gliomas
Safety/Tolerability; incidence of adverse events
Secondary outcome measures
Clinical Activity according to RECIST v 1.1 (2009) for patients with solid tumors, by RANO (2010) criteria for patients with glioma
Pharmacodynamic levels of 2-HG
Pharmacodynamic levels of AG-881
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AG881Experimental Treatment1 Intervention
AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression, development of other unacceptable toxicity or Investigator discretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG881
2015
Completed Phase 1
~80
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Who is running the clinical trial?
Agios Pharmaceuticals, Inc.Lead Sponsor
52 Previous Clinical Trials
4,111 Total Patients Enrolled
Institut de Recherches Internationales ServierLead Sponsor
87 Previous Clinical Trials
67,037 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have gliomas and have previously been treated with bevacizumab (Avastin), you cannot participate in the study.You have a serious infection that needs strong medicine to treat it, or you have a high fever without a clear reason during the screening visits or when you start taking the study drug (unless the doctor thinks your fever is caused by your tumor).You have unstable or uncontrolled chest pain (angina).You have a history of serious and uncontrolled heart rhythm problems.You have difficulty swallowing, have a shortened intestine, or have a condition that affects how your stomach digests food.You have brain metastases that are causing symptoms or need treatment to control symptoms. You have also received radiation, surgery, or other therapies for your brain metastases within the past month.
Research Study Groups:
This trial has the following groups:- Group 1: AG881
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.
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