Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

Exclusion Criteria

• •First-line treatment with an irinotecan-based regimen (eg, FOLFIRI).
• •Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study.
• •Treatment with chemotherapy, other thiazolidinediones (TZD), RT, surgery, immunotherapy, biological therapy, or any investigational anticancer agent within 4 weeks before start of study treatment.
• •History of any of the following conditions within 6 months before initiating study treatment:
• •* Diabetes mellitus requiring treatment with insulin or TZD agents
• •* Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%)
• •* Severe/unstable angina pectoris
• •* Coronary/peripheral artery bypass graft
• •* New York Heart Association (NYHA) class III or IV congestive heart failure
• •* Malabsorption syndrome, chronic diarrhea (lasting \> 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
• •Participants with clinically active brain metastases (defined as untreated, symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms); uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. Participants with treated brain metastasis will be included in the study if they have recovered from the acute, toxic effects of RT. A minimum of 15 days must have elapsed between the end of RT and enrollment into the study.
• •History of malignancy other than CRC, unless there is an expectation that the malignancy has been cured, and tumor-specific treatment for the malignancy has not been administered within the previous 5 years.
• •Clinically significant, severe, active infection requiring IV antibiotic or antiviral agents.
• •Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
• •Need for concomitant use of other TZD agents during the study.
• •Previous administration of CS-7017.
• •Pregnant or breast feeding.
• •Known to be homozygous for the UGT1A1\*28 allele.
• •Known history of severe hypersensitivity reactions to any of the components of CS-7017, irinotecan, leucovorin, or 5-FU.
• •Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment.