Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation
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Study description
This study was done to test a new cancer drug called vorasidenib (also called AG-881) in patients with advanced solid tumors, including glioma.
Solid tumor cancers are abnormal growths of cells in organ(s) of the body such as the lung, breast, or brain. In advanced stages of the disease, solid tumors may spread in other parts of the body.
Glioma is a type of brain cancer that begins in ‘glial’ cells (the cells that surround and support nerve cells). It is a serious and rare disease with few effective treatment options.
In several types of cancer such as gliomas, an abnormal (mutated) form of a protein called isocitrate dehydrogenase (IDH) is present in the tumor cells due to changes called mutations. In the body, there are two types of IDH proteins: IDH1 and IDH2. When IDH1 or IDH2 is mutated, it produces too much of 2 hydroxyglutarate (2-HG), which is a substance that is normally present in cells in low levels. When there is too much 2-HG, it impairs normal cell functioning and may cause the cells to become tumor cells.
Vorasidenib blocks the activity of abnormal IDH proteins.
The study included participants with glioma and participants with non-glioma solid tumors (solid tumors other than glioma).
The main objectives of this study were:
- To look at the safety of vorasidenib.
- To find the highest dose of vorasidenib that participants could take without too much risk (highest tolerated dose). This highest tolerated dose helps to find the recommended dose (the one that is be both safe and effective for patients).
English (USA)- AG881
- AG881-C-002
Eligibility Criteria
Eligible age for the study
Sex
Male/FemaleAccepts Healthy Volunteers
NoTo take part in the study, participants had to:
- Be at least 18 years old.
- Have a solid tumor:
- with an IDH1 and/or IDH2 mutation.
- that worsened despite treatment or came back after treatment (recurred) or did not respond to standard cancer treatments and/or medicines that block the activity of IDH proteins, or for which the doctor believed that there is no suitable treatment.
- Have been able to care for themselves and spend more than half the day out of bed or chair.
- Have good blood, kidney and liver function.
Participants could not take part in the study if:
- They had received prior anticancer medicines or radiation therapy within 21 days before starting the study.
- There was another treatment option available to treat their cancer.
How is the study designed?
Patients took AG-881 by mouth every day, in 28-day cycles. They kept taking AG-881 until their disease worsened, they did not have too severe side effects, or the doctor decided to stop the treatment.