A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid Malignancies

Exclusion Criteria

• •1. Patients who have received chemotherapy within three weeks of E7974 treatment start (6 weeks for a nitrosourea).
• •2. Patients who have not recovered from any chemotherapy-related or other therapy-related toxicity to \<= Grade 1 at study entry (excluding Grade 2 alopecia).
• •3. Patients who have received radiotherapy \<= 3 weeks prior to study enrollment, whose marrow exposure has exceeded 25% and who have not recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia).
• •4. Patients who have had major surgery without full recovery or major surgery within three weeks of E7974 treatment start.
• •5. Patients with primary brain tumors or metastasis at study entry must have controlled them for \>= 1 month by previous treatment, including radiation therapy and corticosteroids.
• •6. Women who are pregnant or breastfeeding.
• •7. Women of childbearing potential with either a positive serum pregnancy test at screening or no pregnancy test.
• •8. Women of childbearing potential unless (1) surgically sterile, (2) physiologically postmenopausal for \>= 12 months, or (3) using adequate measures (including barrier methods) of contraception.
• •9. Fertile men or their partners who are not willing to use contraception.
• •10. Patients who have a history of positive testing for Human Immunodeficiency Virus (HIV) and/or have active hepatitis B or active hepatitis C at study entry.
• •11. Patients with severe, uncontrolled intercurrent illness or infection.
• •12. Patients with medically uncontrolled cardiovascular illness defined as unstable angina, \>= symptomatic Grade II New York Heart Association (NYHA) Classification congestive heart failure (CHF), or myocardial infarction within six months prior to study entry.
• •13. Patients who have received organ allografts requiring immunosuppressive therapy.
• •14. Patients who have received investigational drugs including immunotherapy, gene therapy, hormone therapy, biologic therapy, or chemotherapy within the three-week period prior to E7974 treatment start; patients must have recovered from any previous major therapy-related toxicities (Grade 3 or 4) to \<= Grade 1 at study entry (excluding Grade 2 alopecia).
• •15. Patients with a current history of peripheral neuropathy \> CTC Grade 1 (e.g., diabetic or chemotherapy-induced neuropathy).
• •16. Patients with a history of uncontrolled seizures.
• •17. Patients with marked baseline prolongation of QT/QTc interval (QTc interval \>470) using the Fridericia method as the main method of QTc analysis.
• •18. Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study.
• •19. Patients with allergy or hypersensitivity to hemiasterlin based product or analogue.