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IDH1 Inhibitor
Ivosidenib for Advanced Solid Cancers, Lymphoma & Histiocytosis
Phase 2
Waitlist Available
Led By Elizabeth D Alva
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment)
Patients must be >= than 12 months and =< 21 years of age at the time of study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test ivosidenib to see if it can help patients with advanced solid tumors, lymphoma, or histiocytic disorders that have IDH1 mutations.
Who is the study for?
This trial is for young patients aged between 12 months and 21 years with advanced solid tumors, lymphoma, or histiocytic disorders that have a specific genetic change (IDH1 mutation). They must be able to swallow tablets, have not used IDH1 inhibitors before, and meet certain health criteria like adequate blood counts and organ function. Pregnant individuals or those on certain medications are excluded.Check my eligibility
What is being tested?
The trial is testing Ivosidenib's effectiveness in treating cancers with IDH1 mutations. It's a phase II study focusing on whether this drug can stop cancer cells from growing by targeting the IDH pathway—a critical cell signaling route involved in tumor development.See study design
What are the potential side effects?
While the exact side effects of Ivosidenib aren't listed here, similar drugs often cause issues like diarrhea, fatigue, joint pain or swelling, skin problems, nausea. There may also be more serious risks such as liver problems or an abnormal heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy for cancer treatment.
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I am between 12 and 21 years old.
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I can swallow pills without any issues.
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My body surface area is at least 0.78 square meters.
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I have received a stem cell infusion, with or without total body irradiation.
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I have received external beam radiation therapy.
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I have not undergone radiopharmaceutical therapy.
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I was assigned a specific treatment in the APEC1621SC study due to a certain mutation.
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I have never taken AG-120 (ivosidenib) or any IDH1 inhibitor.
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My kidney function, measured by creatinine clearance or GFR, is good.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR; complete response + partial response) in pediatric patients treated with ivosidenib
Secondary outcome measures
Percentage of patients experiencing grade 3 or higher adverse events
Preliminary estimates of the pharmacodynamics (PD) of ivosidenib in children and adolescents with relapsed or refractory cancer
Preliminary estimates of the pharmacokinetics (PK) of ivosidenib in children and adolescents with relapsed or refractory cancer
+1 moreOther outcome measures
Biomarker analysis
Profiling changes in tumor genomics
Side 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: Treatment (ivosidenib)Experimental Treatment1 Intervention
Patients receive ivosidenib PO QD. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivosidenib
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Children's Oncology GroupNETWORK
453 Previous Clinical Trials
237,651 Total Patients Enrolled
4 Trials studying Germ Cell Tumors
3,961 Patients Enrolled for Germ Cell Tumors
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,618 Total Patients Enrolled
7 Trials studying Germ Cell Tumors
3,840 Patients Enrolled for Germ Cell Tumors
Elizabeth D AlvaPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.My white blood cell count is healthy for cancer treatment.I am between 12 and 21 years old.I can swallow pills without any issues.My platelet count is at least 100,000/mm^3 without needing transfusions for the last week.I do not have any infections that are currently uncontrolled.My body surface area is at least 0.78 square meters.Your blood protein level (serum albumin) is at least 2 grams per deciliter within the week before joining the study.I can do most activities, but may need help, or I'm in a wheelchair but active.I have received a stem cell infusion, with or without total body irradiation.You are currently taking other medications to treat cancer.My cancer can be seen on scans, or if I have neuroblastoma, it shows up on special tests.I have received external beam radiation therapy.I have seizures but they are well controlled with medication.My nervous system side effects from previous treatments are mild.The level of SGPT (a liver enzyme) in your blood should be no more than 3 times the normal upper limit (45 U/L) before you can join the study.I am not taking drugs that strongly affect liver enzyme CYP3A4.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.I have had progressive multifocal leukoencephalopathy in the past.I have not undergone radiopharmaceutical therapy.Your heart's electrical activity, called the QT interval, should be less than or equal to 450 milliseconds when measured within 7 days before joining the study.I was assigned a specific treatment in the APEC1621SC study due to a certain mutation.I have recovered from side effects of previous cancer treatments.I have never taken AG-120 (ivosidenib) or any IDH1 inhibitor.My bilirubin levels are within the normal range for my age.You have had an organ transplant in the past.My kidney function, measured by creatinine clearance or GFR, is good.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ivosidenib)
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.
Are the subjects of this experiment middle-aged or older?
"According to the eligibility requirements for this study, infants as young as 12 months old up through 21-year-olds are allowed to participate."
Answered by AI
Has Ivosidenib been studied before in other medical trials?
"The first trial for ivosidenib was completed in 2014, with 6 total trials having been completed as of now. Out of the 22 active studies being conducted, a plurality are based in Las Vegas, Nevada."
Answered by AI
Are there any life-threatening risks associated with Ivosidenib?
"Since this is a Phase 2 trial, there is only some data supporting safety rather than efficacy. Therefore, the Power team rates Ivosidenib as a 2 in terms of safety."
Answered by AI
Are we still able to enroll in this research program?
"Yes, recruitment is still open for this study according to the latest update on clinicaltrials.gov. This research was first made public on June 8th, 2020 and has since been updated on November 9th, 2020. So far, 49 people have enrolled at 100 different sites."
Answered by AI
Who might be a good candidate for this experiment?
"This clinical trial is looking for 49 individuals that have been diagnosed with wilms tumor. The applicants must be aged 12 months to 21 years old and meet the following additional requirements: lesions only detectable through nuclear medicine studies, enrolled in APEC1621SC, given treatment assignment to MATCH based on the presence of an actionable mutation, able to swallow intact tablets, have radiographically measurable disease (or MIBG+ evaluable disease for neuroblastoma patients), a body surface area of at least 0.78 m^2 , no previous radiation therapy for lesions that have not progressed post-radiation."
Answered by AI
Where are patients able to enroll in this research?
"One hundred different hospitals or clinics are running this study currently. If you enroll, it would be convenient to select a location near you from the list of 100 total locations, which include: Las Vegas, Indianapolis and Royal Oak among others."
Answered by AI
How many research participants are being asked to join this clinical trial?
"Yes, this is an ongoing trial that was posted on clinicaltrials.gov on 6/8/2020. The last edit to the posting was made 11/9/2022. They are looking for 49 patients who will participate at 100 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
What site did they apply to?
University of Nebraska Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I was diagnosed in 2017!!! No one told me ANYTHING I SWEAR!!Sooo all that I know iv researched myself. I did. go to CA DR HE SAYS HE NEVER HEARD OF IT BEFORE SO I THOUGHT I WAS A FREAK!! So this year I vowed to find out more. So I got appt with Dr Copur in Hastings!! And he really didn’t know much sooo here I sit still no answers!!!!
PatientReceived 1 prior treatment
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