Ivosidenib (AG-120) in Patients with IDH1-mutant Relapsed/Refractory Myelodysplastic Syndrome (MDS) | Aplastic Anemia & MDS International Foundation

ClinicalTrials.gov Identifier:

NCT02074839

Contact Info

Medical Affairs Agios Pharmaceuticals, Inc.

medinfo@agios.com

1-833-228-8474

Dates

Start: September 2019
End: December 2020

Official Title

Ivosidenib (AG-120) in Patients with IDH1-mutant Relapsed/Refractory Myelodysplastic Syndrome (MDS)

Purpose

The study is a sub-study of a Phase 1, dose escalation and expansion study of ivosidenib in patients with mIDH1 advanced hematologic malignancies (NCT02074839) and will be evaluating ivosidenib in subjects with mIDH1 relapsed/refractory (R/R) myelodysplastic syndrome (MDS). Patients must have R/R disease after treatment with standard agents indicated for MDS and high disease burden. The objective of the study is to evaluate the safety, clinical activity, tolerability, pharmacokinetics, and pharmacodynamics of treatment with ivosidenib in patients with mIDH1 R/R MDS.

Ivosidenib (AG-120) in Patients with IDH1-mutant Relapsed/Refractory Myelodysplastic Syndrome (MDS)

Clinical Trial: NCT02074839

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Associated Drug(s): 
Phase: 
Phase 1
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  1. Subject must be ≥18 years of age.
  2. Patients must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation.
  3. Patients must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.
  4. Patients must have ECOG PS of 0 to 2.
  5. Platelet count ≥20,000/µL (Transfusions to achieve this level are allowed).
  6. Patients must have adequate hepatic function as evidenced by: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to leukemic disease and serum total bilirubin ≤1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic disease.
  7. Patients must have adequate renal function as evidenced by a serum creatinine ≤2.0 × ULN or creatinine clearance >40mL/min based on Cockroft-Gault glomerular filtration rate (GFR).
  8. Patients must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.
  9. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy and on the first day of study drug administration.
Exclusion Criteria: 
  1. Patients who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or Patients on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). (The use of a stable dose of oral steroids post HSCT and/or topical for ongoing skin GVHD is permitted).
  2. Patients who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120).
  3. Patients who received an investigational agent <14 days prior to their first day of study drug administration.
  4. Patients who are pregnant or breastfeeding.
  5. Patients with an active severe infection or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, patients with tumor fever may be enrolled).
  6. Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within approximately 28 days of C1D1.
  7. Patients with a history of myocardial infarction within the last 6 months of screening.
  8. Patients with known unstable or uncontrolled angina pectoris.
  9. Patients with a known history of severe and/or uncontrolled ventricular arrhythmias.
  10. Patients with heart-rate corrected QT (QTc) interval ≥450 ms or other factors that increase the risk of QT prolongation or arrhythmic events.
  11. Patients taking medications that are known to prolong the QT interval.
  12. Patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.
  13. Patients with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is a clinical suspicion of CNS involvement by leukemia during screening.
  14. Patients with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.

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