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Ivosidenib for Myeloid Neoplasms
Phase 1
Waitlist Available
Led By Amir T Fathi, MD
Research Sponsored by Massachusetts General Hospital
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 from the start of treatment with ivosidenib until the onset of chronic gvhd, up to 24 months
Awards & highlights
Study Summary
This trial is testing ivosidenib (AG-120) to see if it can treat patients with IDH1-mutant myeloid neoplasms.
Eligible Conditions
- IDH1 Mutation Myeloid Neoplasms
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment with ivosidenib until the onset of chronic gvhd, up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment with ivosidenib until the onset of chronic gvhd, up to 24 months
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
Secondary outcome measures
Cumulative incidence of acute GVHD
Cumulative incidence of chronic GVHD
IDH clonal evolution and mutational burden
+2 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
2Treatment groups
Experimental Treatment
Group I: Ivosidenib (500mg/day)Experimental Treatment1 Intervention
-Ivosidenib will be administered orally every day
Group II: Ivosidenib (250mg/day)Experimental Treatment1 Intervention
-Ivosidenib will be administered orally every day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivosidenib
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,427 Total Patients Enrolled
Agios Pharmaceuticals, Inc.Industry Sponsor
52 Previous Clinical Trials
4,188 Total Patients Enrolled
Amir T Fathi, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
172 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious infection that required intravenous antibiotics within the past week before starting the study drug.You are planning to have a stem cell transplant for your cancer treatment. The transplant may involve strong or mild conditioning.You had another type of cancer in the past, unless it was a long time ago and is no longer a concern.The only previous cancer you had was non-invasive cervical cancer or non-invasive skin cancers like basal cell or squamous cell carcinoma.You have a heart condition that can cause dangerous irregular heartbeats.
Research Study Groups:
This trial has the following groups:- Group 1: Ivosidenib (500mg/day)
- Group 2: Ivosidenib (250mg/day)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
To what extent have previous investigations utilized Ivosidenib?
"Ivosidenib was first investigated at NCT02074839 in 2014 and has since seen 6 successful trials. Currently, 21 clinical studies are enrolling participants with a considerable amount of these experiments taking place around Baltimore, Maryland."
Answered by AI
How many participants is the clinical trial taking on?
"This clinical trial is no longer enrolling patients, as the last update was made on October 25th 2021. Nevertheless, there are 2,400 cancer-related studies currently recruiting and an additional 21 trials for Ivosidenib open to participation."
Answered by AI
Are there any available opportunities to participate in this research trial?
"Clinicaltrials.gov has the latest information on this medical trial, which began in January 2019 and was last updated in October 2021; it is not currently recruiting patients. Although no longer open to recruitment, 2400 other trials are actively searching for participants at this time."
Answered by AI
To what extent can Ivosidenib be hazardous to patients?
"Our experts at Power score the safety of Ivosidenib with a 1 due to its early phase in development and minimal evidence supporting efficacy."
Answered by AI
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