Phase II Study of Vemurafenib and Sorafenib for Pancreatic Cancer

Inclusion Criteria

• Must understand and agree to sign a consent form before starting the trial.
• Must be 18 years or older.
• Have confirmed pancreatic cancer with a KRAS mutation that has spread and worsened after at least two previous treatments.
• Must know the mutation status of KRAS and BRAF genes. If not known, a previous tumor sample must be available for testing.
• Must be in good general health with a performance status of 0 or 1.
• Must have good organ function.
• Women of childbearing age must have a negative pregnancy test before starting the trial. Post-menopausal or surgically sterilized women do not need a pregnancy test.
• Women must not be pregnant or breastfeeding and must agree to use birth control during the trial and for 30 days after the last dose.
• Men must agree to use birth control during the trial and for 30 days after the last dose and not donate sperm during this time.
• Must have a heart rhythm (QTC) of 500ms or less.
• Must be able to swallow pills.
• Must have measurable disease according to specific criteria.

Exclusion Criteria

• Currently participating in another trial or have used an investigational drug or device within 2 weeks before starting this trial.
• Have had chemotherapy, targeted therapy, or radiation within 2 weeks before starting the trial or have not recovered from side effects of previous treatments.
• Have used BRAF inhibitors like vemurafenib or sorafenib before.
• Have had major surgery and not fully recovered.
• Have another untreated or active cancer, except for certain skin or cervical cancers.
• Have active brain metastases or cancer in the brain lining.
• Have uncontrolled high blood pressure.
• Have significant heart disease.
• Have a history of lung inflammation requiring steroids or current lung inflammation.
• Have an active infection needing treatment.
• Have a history of bleeding disorders.
• Have had recent significant bleeding events.
• Have had recent blood clots or strokes.
• Have non-healing wounds or fractures.
• Have had an organ transplant.
• Have allergies to the study drugs.
• Have Neurofibromatosis Type 1 or other RAS-related disorders.
• Have uncontrolled seizures.
• Are taking medications that affect heart rhythm or certain enzymes within 14 days before starting the trial.
• Have absorption issues or significant bowel or stomach surgery.
• Have any condition or treatment that might interfere with the trial.
• Have psychiatric or substance abuse issues that would affect participation.
• Are unable to comply with the trial requirements.