Study Comparing Velzatinib and Imatinib for Untreated Metastatic or Unremovable Gastrointestinal Stromal Tumors

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of GIST that has spread or cannot be surgically removed.
• Have not received any prior treatment for their metastatic or unremovable GIST.
• Must provide a tumor sample for testing, either from a previous biopsy or a new one.
• Must have at least one measurable tumor.
• Must agree to use effective contraception during the study and for a specified time after the last dose.
• Male participants must use a condom and avoid donating semen.
• Female participants must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
• Must be able to give informed consent and follow study requirements.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have adequate organ function.

Exclusion Criteria

• Have another cancer that has progressed or needed treatment in the past 24 months, except for certain skin or in-situ cancers.
• Have significant digestive issues that affect absorption, like malabsorption syndrome.
• Have had major surgery within 14 days before starting the study treatment.
• Have had a bone marrow or organ transplant, except for certain stem cell transplants under specific conditions.
• Have allergies to velzatinib or imatinib that would prevent participation.
• Have serious heart conditions or recent heart attacks.
• Have untreated or worsening brain metastases.
• Have ongoing side effects from previous treatments that haven't improved.
• Have serious kidney issues or need dialysis.
• Have serious medical or psychiatric conditions that could interfere with the study.
• Have received radiation therapy within 14 days before starting the study.
• Have received a live vaccine within 30 days before starting the study.
• Have received blood transfusions or certain growth factors within 14 days before starting the study.
• Are participating in another clinical study.
• Have a positive drug or alcohol test.
• Have uncontrolled HIV infection or certain HIV-related conditions.
• Are pregnant or breastfeeding.
• Cannot follow the study protocol.
• Have high liver enzyme levels or liver disease.
• Have chronic hepatitis B with a detectable viral load.
• Have a prolonged QT interval on an ECG or a history of long QT syndrome.