Study on MEK162 and Imatinib for Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

Inclusion Criteria

• Must have a confirmed diagnosis of Gastrointestinal Stromal Tumor (GIST).
• For Phase Ib, must have advanced GIST that has worsened despite treatment with Imatinib.
• For Phase II, must be newly diagnosed or have not received treatment, or have stopped Imatinib for at least 3 months. Patients who started Imatinib up to 4 weeks before joining can also participate.
• Must be 18 years or older.
• Disease must be measurable by standard criteria.
• Must be in good general health with a performance status of 0 or 1.
• Must have good kidney, liver, and blood function as shown by specific blood tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use birth control during and for 3 months after treatment.
• Must have good heart function and be able to take oral medications.
• Must agree to participate and sign a consent form.

Exclusion Criteria

• For Phase II, cannot have had previous systemic therapy for GIST, except for certain cases with Imatinib.
• Cannot have severe or uncontrolled medical conditions like uncontrolled diabetes or infections.
• Cannot have known brain metastasis or chronic liver disease.
• Cannot have active HIV, Hepatitis B, or Hepatitis C infections.
• Cannot have other active cancers that might interfere with the study.
• Cannot have certain eye conditions or a history of retinal diseases.
• Cannot have significant heart disease or uncontrolled high blood pressure.
• Cannot have muscle disorders that raise certain enzyme levels.
• Cannot have uncontrolled digestive issues.
• Cannot have used a MEK inhibitor before.
• Cannot have had major surgery within 3 weeks before the study.
• Cannot be pregnant or breastfeeding.
• Sexually active men must use condoms during and shortly after treatment.
• Cannot have a history of not following medical advice or be unable to give informed consent.