Phase III Double-blinded, Placebo Controlled Study of Xilonix? for Improving Survival in Metastatic Colorectal Cancer
The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.
- drug : Placebo
- drug : Xilonix
Phase: Phase 3
Ages Eligible For Study:
1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with standard approved regimens including, oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype. 2. Subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2. 4. At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics. 5. Age ? 18 years, male or female subjects. 6. Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. 7. Adequate renal function, defined by serum creatinine ? 1.5 x ULN. 8. Adequate hepatic function 9. Adequate bone marrow function 10. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening. 11. Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed. 12. Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.