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Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

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Servier Protocol Code: AG120-C-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02074839 EudraCT Number: 2014-000480-40

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 30 locations

Study description

The study is needed to test a drug called ivosidenib in patients with advanced blood cancers (hematologic malignancies) that have a change in a specific gene (mutation) called isocitrate dehydrogenase 1 (IDH1).

IDH1 mutations lead to abnormal forms of IDH1 proteins in the cancer cells. When these abnormal proteins are present, too much of a substance called 2-hydroxyglutarate (2-HG) is produced. This impairs normal cell functioning and may cause cells to become cancer cells.

Ivosidenib is a drug that blocks the activity of abnormal IDH1 proteins. This reduces 2-HG levels in cancer cells back to normal levels. Ivosidenib has already been approved in certain countries for treating patients with different types of cancer with an IDH1 mutation.

The main goals of the study are:

  • To see how safe and well-tolerated ivosidenib is in participants with advanced blood cancer with an IDH1 mutation.
  • To find the highest dose of ivosidenib that participants can take without too much risk (highest tolerated dose). This highest tolerated dose helps to find the recommended dose (the one that is both safe and effective for patients).
  • To see how well ivosidenib works in treating advanced blood cancer with an IDH1 mutation.
Official title: A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Conditions
Relapsed or Refractory Acute Myeloid Leukemia (AML) Untreated AML Other IDH1-mutated Positive Hematologic Malignancies Myelodysplastic Syndromes
Interventions / Treatments
  • AG-120
Other study id numbers
  • AG120-C-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be at least 18 years old.
  • Have advanced blood cancer with an IDH1 mutation.
  • Be able and willing to undergo required sampling procedures, including bone marrow and blood sampling. Bone marrow sampling involves a minor surgical procedure.

Participants cannot take part in the study if:

  • They have previously received a drug that blocks IDH1.
  • They have received anticancer medicines or radiation therapy within 14 days before starting the study.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: AG-120

Participants take the study treatments during time periods called “cycles”. Participants take AG-120 orally every day, over 28-day cycles. 

Intervention / Treatment
Drug: AG-120

Keywords

Provided by Servier
acute myeloid leukemia AML myelodysplastic syndrome MDS hematologic malignancies IDH Untreated AML IDH1 relapsed AML refractory AML
Additional Relevant MeSH Terms Glioma
Recurrence Leukemia, Myeloid, Acute Myelodysplastic Syndromes Hematologic Neoplasms