Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

• •Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
• •For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.
• •At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
• •Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
• •At least 4 weeks have elapsed since any major surgery.
• •Have ECOG performance status of 0, 1, or 2.
• •Have adequate bone marrow and organ function