Phase I Study of CPI-300 in Patients With Advanced Tumors

- Have a histologically or cytologically confirmed diagnosis of advanced solid tumor

- Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy

- Have an ECOG performance status of 0-1

- Have adequate bone marrow reserve, liver and renal function

- Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment

- Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding

- Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment

- Have peripheral neuropathy of Grade 3 or Grade 4 at screening

- Have peripheral sensory neuropathy of Grade 2 or greater at screening

- Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator

- Have known hypersensitivity to chemotherapeutic agents

- Have chronic diarrhea

- Have a history of thrombocytopenia with complications including hemorrhage or bleeding > Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe

- Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia

- Received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of treatment

- Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions

- Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy

- Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study

- Is pregnant or breast-feeding