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AG-120 for Myelodysplastic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic Syndrome+3 MoreAG-120 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, AG-120, to see if it's safe and effective in treating people with advanced cancers that have a mutation in the IDH1 gene. The trial has two parts: first, they'll test different doses of the drug to see what the maximum tolerated dose is; then, they'll expand the trial to a larger group of people to see if the drug is effective. There's also a substudy testing AG-120 in people with a different but related cancer, myelodysplastic syndrome.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Relapsed or Refractory Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • Other IDH1-Mutated Positive Hematologic Malignancies

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 8 Secondary · Reporting Duration: up to 26 weeks, on average

Week 26
Assess clinical activity of AG-120 in subjects with relapsed or refractory AML who are enrolled in the Expansion Phase.
Assess clinical activity of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome.
Blood and bone marrow sampling at specified time points for determination of 2-HG levels to characterize the percent of 2-HG inhibition of AG-120 in plasma and bone marrow.
Clinical Activity of AG-120 in advanced hematologic malignancies according to the 2003 revised IWG criteria for AML or the 2006 modified IWG criteria for MDS or MDS/myeloproliferative neoplasms (MPN).
Dose Limiting Toxicities of AG-120 in subjects with advanced hematologic malignancies.
Maximum Tolerated Dose and/or the recommended Phase II dose of AG-120 in subjects with advanced hematologic malignancies.
Pharmacodynamic relationship of AG-120 and 2-HG.
Pharmacokinetics of AG-120 in subjects with advanced hematologic malignancies.
Safety/tolerability of treatment with AG-120 in subjects with relapsed or refractory myelodysplastic syndrome.
Safety/tolerability: incidence of adverse events.
Serial blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters (AUC) of AG-120 in subjects with R/R MDS.
Serial blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters (Cmax) of AG-120 in subjects with R/R MDS.
Serial blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters (Tmax) of AG-120 in subjects with R/R MDS.

Trial Safety

Safety Progress

1 of 3

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Side Effects for

AG-120
42%Nausea
35%Diarrhoea
31%Fatigue
25%Cough
24%Abdominal pain
24%Decreased appetite
23%Vomiting
20%Ascites
19%Anaemia
16%Constipation
14%Oedema peripheral
14%Asthenia
13%Back pain
13%Pyrexia
13%Headache
11%Arthralgia
11%Aspartate aminotransferase increased
11%Abdominal distension
11%Hyponatraemia
10%Insomnia
10%Dyspnoea
10%Blood bilirubin increased
9%Electrocardiogram QT prolonged
9%Blood alkaline phosphatase increased
9%Alanine aminotransferase increased
9%Hypertension
8%Rash
8%Weight decreased
8%Abdominal pain upper
8%Hypokalaemia
7%White blood cell count decreased
7%Gastrooesophageal reflux disease
7%Chills
7%Hypomagnesaemia
7%Hypoalbuminaemia
7%Hyperglycaemia
7%Neuropathy peripheral
6%Urinary tract infection
6%Dizziness
6%Pruritus
6%Blood creatinine increased
6%Platelet count decreased
6%Dyspepsia
5%Muscle spasms
5%Hyperkalaemia
5%Hypophosphataemia
3%Pneumonia
3%Confusional state
3%Upper respiratory tract infection
3%Sepsis
3%Abdominal discomfort
3%Rash maculo-papular
2%Escherichia bacteraemia
2%Intestinal obstruction
2%Hyperbilirubinaemia
2%Pleural effusion
2%Hypercalcaemia
2%Dry mouth
2%Cholangitis
2%Jaundice cholestatic
2%Hip fracture
1%Non-cardiac chest pain
1%Biliary sepsis
1%Device related infection
1%Hepatic encephalopathy
1%Upper gastrointestinal haemorrhage
1%Bile duct stenosis
1%Blood loss anaemia
1%Pain
1%Abdominal infection
1%Biliary tract infection
1%Gamma-glutamyltransferase increased
1%Staphylococcal infection
1%Dysphagia
1%Vertigo
1%Gastrointestinal haemorrhage
1%Biliary obstruction
1%Hepatic haemorrhage
1%Jaundice
1%Bacterial infection
1%Gastroenteritis
1%Dehydration
1%Failure to thrive
1%Localised oedema
1%Renal failure
1%Parainfluenzae virus infection
1%Mental status changes
1%Pulmonary embolism
1%Hepatic failure
1%Large intestinal obstruction
1%Cholangitis acute
1%Cholecystitis
1%Arterial injury
1%Cognitive disorder
1%Fall
1%Muscular weakness
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT02989857) in the AG-120 ARM group. Side effects include: Nausea with 42%, Diarrhoea with 35%, Fatigue with 31%, Cough with 25%, Abdominal pain with 24%.

Trial Design

1 Treatment Group

AG-120
1 of 1

Experimental Treatment

291 Total Participants · 1 Treatment Group

Primary Treatment: AG-120 · No Placebo Group · Phase 1

AG-120
Drug
Experimental Group · 1 Intervention: AG-120 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivosidenib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 26 weeks, on average

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor
77 Previous Clinical Trials
68,764 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.
Subjects must have adequate hepatic function as evidenced by: AST, ALT, and ALP ≤3.0 x ULN, unless considered due to leukemic disease and serum total bilirubin ≤1.
You must be at least 18 years of age to donate blood.
Subjects must have adequate renal function as evidenced by a serum creatinine ≤2.
You are female and have reproductive potential
Platelet count ≥20,000/µL.
References

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