Study on AG-120 for People with IDH1 Mutant Chondrosarcoma

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of advanced or recurrent chondrosarcoma (grade 2 or 3) based on a tumor biopsy.
  • Patients with low-grade (grade 1) or dedifferentiated chondrosarcoma are not eligible.
  • Patients with low-grade pelvic chondrosarcoma may be eligible if imaging suggests a higher grade.
• Have a confirmed IDH1 gene mutation from a tumor sample.
• Have a performance status score of 0 to 2, indicating good overall health.
• Expected to live at least 4 more months.
• Have at least one measurable tumor.
• Have shown disease progression in the last 4 months.
• Have recovered from previous cancer treatment side effects.
• Have adequate bone marrow, liver, and kidney function based on specific blood tests.
• Be able to understand and sign a consent form, or have a representative do so.
• Be able to swallow pills.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 90 days after.
• Men and their partners must agree to use effective birth control during the study and for 90 days after.

Exclusion Criteria

• Have previously taken an IDH1 inhibitor.
• Have had cancer treatment or investigational drugs within 3 weeks before starting the study.
• Have had radiation or local treatment to cancer sites within 2 weeks before starting the study.
• Have had major surgery within 4 weeks before starting the study.
• Have untreated or symptomatic brain metastases requiring steroids.
• Have another active cancer needing treatment.
• Are pregnant or breastfeeding.
• Are taking certain medications that affect the liver or heart unless they can be switched to other medications.
• Have an active infection or unexplained fever.
• Have allergies to AG-120 components.
• Have significant heart disease or low heart function.
• Have a prolonged QT interval on an ECG or are taking medications that prolong the QT interval.
• Have active hepatitis B or C, or HIV.
• Have any other serious medical or psychiatric conditions that could interfere with the study.
• Have gastrointestinal conditions that affect drug absorption.
• Have a history of progressive multifocal leukoencephalopathy (PML).