Phase I/Ib Study of Paclitaxel in Combination With VS-6063 in Patients With Advanced Ovarian Cancer

Exclusion Criteria

• •1. Gastrointestinal (GI) condition which could interfere with the swallowing or absorption of study medication.
• •2. Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases). Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants, with no dose change within 28 days prior to the first dose of study drug, will be allowed.
• •3. History of upper gastrointestinal bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug.
• •4. Known history of Gilbert's Syndrome.
• •5. Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug.
• •6. Subjects with known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) (testing not required).
• •7. Subjects with Hepatitis A, B or C (testing not required).
• •8. Subjects being actively treated for a secondary malignancy.
• •9. Cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) within 28 days of the first dose of study drug or 5 half-lives, whichever is shorter.
• •10. Major surgery within 28 days prior to the first dose of study drug.
• •11. Use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug. A minimum of 10 days between termination of the investigational drug and administration of the study treatment is required. In addition, any drug-related toxicity except alopecia should have recovered to grade 1 or less.
• •12. Pregnant or breastfeeding.
• •13. Any evidence of serious active infections.
• •14. Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis.
• •15. Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.