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IDH1 Inhibitor
AG-120 for Solid Tumors
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks, on average
Awards & highlights
Study Summary
This trial is testing a new drug, AG-120, to see if it is safe and effective in treating patients with advanced solid tumors that have a specific genetic mutation. The trial has two parts: a dose escalation phase to find the best dose of the drug, and a dose expansion phase to further test the drug's safety and effectiveness.
Who is the study for?
Adults with advanced solid tumors or glioma carrying an IDH1 mutation, who have tried standard treatments without success or cannot tolerate them. Participants must be in good general health with proper organ function and not have had certain recent treatments. Women of childbearing potential and fertile men must agree to use effective contraception.Check my eligibility
What is being tested?
AG-120, an oral medication, is being tested for safety and effectiveness in two phases: dose escalation to find the maximum tolerated dose and expansion to assess its impact at that dose on various cancers with IDH1 mutations.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to AG-120 which could include typical drug-related symptoms such as nausea, fatigue, liver issues, or other organ-specific effects.
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 AG-120 in subjects with advanced solid tumors, including glioma
Safety/tolerability: incidence of adverse events
Secondary outcome measures
Clinical Activity associated with AG-120 in subjects with advanced solid tumors, including glioma
Dose Limiting Toxicities of AG-120 in subjects with advanced solid tumors, including glioma
Pharmacodynamic relationship of AG-120 and 2-HG
+1 moreSide effects data
From 2021 Phase 3 trial • 187 Patients • NCT0298985728%
Nausea
28%
Diarrhoea
23%
Fatigue
21%
Oedema peripheral
16%
Abdominal pain
16%
Anaemia
14%
Decreased appetite
14%
Weight decreased
12%
Vomiting
12%
Asthenia
12%
Cough
12%
Ascites
12%
Constipation
12%
Arthralgia
9%
Hypertension
9%
Abdominal pain upper
9%
Dizziness
9%
Muscle spasms
9%
Muscular weakness
9%
Dyspnoea
9%
Blood alkaline phosphatase increased
7%
Upper respiratory tract infection
7%
Hypoalbuminaemia
7%
Pruritus
7%
Hypophosphataemia
7%
Aspartate aminotransferase increased
7%
Alanine aminotransferase increased
7%
Insomnia
7%
Abdominal discomfort
5%
Hypokalaemia
5%
Rash
5%
Back pain
5%
White blood cell count decreased
5%
Hyperglycaemia
5%
Hyperkalaemia
5%
Pyrexia
5%
Headache
5%
Abdominal distension
5%
Blood bilirubin increased
5%
Confusional state
5%
Platelet count decreased
2%
Electrocardiogram QT prolonged
2%
Chills
2%
Cholangitis
2%
Gastrointestinal haemorrhage
2%
Intestinal pseudo-obstruction
2%
Biliary obstruction
2%
Bacteraemia
2%
Clostridium difficile colitis
2%
Escherichia bacteraemia
2%
Hip fracture
2%
Hypercalcaemia
2%
Encephalopathy
2%
Acute kidney injury
2%
Hypotension
2%
Gastrooesophageal reflux disease
2%
Hypomagnesaemia
2%
Blood creatinine increased
2%
Dyspepsia
2%
Urinary tract infection
2%
Rash maculo-papular
2%
Dry mouth
2%
Multiple sclerosis relapse
2%
Spinal cord compression
2%
Syncope
2%
Hyponatraemia
2%
Hepatic cirrhosis
2%
Oesophageal varices haemorrhage
2%
Upper gastrointestinal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
After Cross Over to AG-120
AG-120
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: AG-120Experimental Treatment1 Intervention
AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with AG-120 until disease progression, development of other unacceptable toxicity or Investigator discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
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
66,962 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The amount of medication given to you will gradually increase over time.You have treatment options available that could potentially cure your cancer.If you have cholangiocarcinoma, you must have a tumor that can be seen on a radiograph in a location that has not been treated before. If the tumor has been treated before, there must be a new area of tumor growth that can be measured by a radiologist.You have chondrosarcoma with a specific gene mutation (IDH1) that cannot be fully removed by surgery and has either spread or is locally advanced.The trial is looking for participants with a specific type of brain tumor called non-enhancing glioma for the dose expansion phase.The study is specifically looking for patients with chondrosarcoma for further testing.You have had a heart attack within the past 6 months.You have advanced solid tumors, including glioma, with a specific IDH1 gene mutation that have not responded to standard treatment or have come back after treatment.You have been diagnosed with a type of liver cancer called cholangiocarcinoma that has mutations in the IDH1 gene. The cancer is in an advanced stage and cannot be treated with surgery or other therapies that remove or destroy the cancer cells. Tumors that have a mix of different types of cells are not allowed.If you have cholangiocarcinoma, you must have already tried a treatment that included gemcitabine and your condition has gotten worse.You have a measurable tumor according to specific medical guidelines (RECIST v1.1 or RANO criteria).You cannot have taken any experimental medication within 14 days before starting this study. Also, you should wait for at least 5 half-lives of the experimental medication before taking the first dose of AG-120.You have a type of bone cancer called chondrosarcoma that has a mutation in the IDH1 gene. The cancer has either spread or is too large to be removed completely by surgery.You have a severe infection that requires medication, or a fever with no clear cause above 38.5°C during screening or at the start of the study drug.You have a medical condition that makes it difficult for you to swallow or absorb medicine through your stomach.The study is looking for participants with a specific type of cancer called cholangiocarcinoma for further testing.
Research Study Groups:
This trial has the following groups:- Group 1: AG-120
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.
What potential risks do patients face when taking AG-120?
"AG-120's safety rating is 1 due to its status as a Phase 1 trial, meaning that the available evidence of both efficacy and safety is limited."
Answered by AI
How many individuals are actively taking part in this trial?
"This clinical trial has ceased actively seeking participants, with the initial post on March 1st 2014 and most recent update occurring July 29th 2022. For those looking for other studies related to glioma, there are 570 active trials while 21 further studies involve AG-120."
Answered by AI
To what extent has this trial been implemented in North American medical centers?
"Presently, 11 medical sites are hosting this clinical trial. These locations spread across Houston, Dallas and Los Angeles as well other cities in the US of A. To avoid long commutes, patients should select a clinic closest to their current residence if they decide to participate."
Answered by AI
Are new entrants still being accepted for enrollment in this clinical trial?
"As per the information located on clinicaltrials.gov, this medical trial is not currently recruiting patients. This study was first posted in March 2014 and last modified at the end of July 2022; however, there are 591 other trials with open enrollment presently."
Answered by AI
Could you provide examples of past investigations involving AG-120?
"AG-120 was initially trialled in 2014 through NCT02074839, with 6 completed clinical trials as of present day. 21 active studies are currently taking place - Houston, Texas is a major hub for these investigations."
Answered by AI
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