Phase I Study of Oral DFP-11207 in Solid Tumors

Exclusion Criteria

• •1. Known allergy to fluoropyrimidines or known dihydropyrimidine dehydrogenase (DPD) deficiency.
• •2. Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for non-cytotoxic agents prior to this study entry.
• •3. Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
• •4. Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
• •5. Pregnant or lactating individuals.
• •6. Current malignancies of another type, with the exception of adequately treated in situ cervical cancer, squamous cell and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
• •7. Known history of HIV, HBV or HCV infection.
• •8. Documented or known bleeding disorder.
• •9. Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the normal range (low dose deep vein thrombosis (DVT) or line prophylaxis is allowed).
• •10. Clinically evident central nervous system metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment.
• •11. Cardiac dysfunction defined as myocardial infarction within 6 months of study entry, New York Heart Association Class III or IV heart failure, uncontrolled dysrhythmias or poorly controlled angina.
• •12. History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row), QTc ≥ 450 msec for men and 470 msec for women, or LVEF ≤ 40% by MUGA or ECHO.