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New treatment option for Relapsed or Refractory Acute Myeloid Leukemia (AML)
Official title Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
ClinicalTrials.gov ID: NCT02074839
What this study is testing
What is AG-120?
AG-120 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsed or refractory acute myeloid leukemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be ≥18 years of age.
- people must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation.
- people must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.
- people must have ECOG PS of 0 to 2.
- Platelet count ≥20,000/µL (Transfusions to achieve this level are allowed).
You likely can't join if
- people who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or people on immunosuppressive...
- people who received systemic anticancer therapy or radiotherapy \<14 days prior to their first day of study drug administration. (Hydroxyurea is...
- people who received an investigational agent \<14 days prior to their first day of study drug administration.
- people who are pregnant or breastfeeding.
- people with an active severe infection or with an unexplained fever \>38.5°C during screening visits or on their first day of study drug...
- people with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \<40% by echocardiogram (ECHO) or multi-gated...
See the full eligibility criteria
- Subject must be ≥18 years of age.
- people must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation.
- people must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.
- people must have ECOG PS of 0 to 2.
- Platelet count ≥20,000/µL (Transfusions to achieve this level are allowed).
- people 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...
- people 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)
- people must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.
- Female people 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. Key
- people who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or people on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant...
- people 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).
- people who received an investigational agent \<14 days prior to their first day of study drug administration.
- people who are pregnant or breastfeeding.
- people 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, people with tumor fever may...
- people 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.
- people with a history of myocardial infarction within the last 6 months of screening.
- people with a known unstable or uncontrolled angina pectoris.
- people with a known history of severe and/or uncontrolled ventricular arrhythmias.
- people with known unstable or uncontrolled angina pectoris.
- people with heart-rate corrected QT (QTc) interval ≥450 ms or other factors that increase the risk of QT prolongation or arrhythmic events.
- Patients taking medications that are known to prolong the QT interval
- people with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.
- people 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...
- people with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Duarte, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Duarte, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.