Seven RVX-208 Strategies Outlined

16 Design The C3 study RVX-208 is a two-arm, multicentre, open label, randomised phase III trial comparing the efficacy and safety of a sequential Cape/5-FU-Bmab with escalation to CapeOX/mFOLFOX6-Bmab compared with a conventional combination CapeOX/mFOLFOX6-Bmab for the first-line treatment of unresectable mCRC. Enrolment A total of 304 patients will be enrolled in a 1:1 randomisation into the two treatment arms. Patients will be enrolled at one of the 80�C100 study centres in Japan. The study started on 1 December 2014. The estimated primary completion date, which is the final data collection date for primary outcome measure, is November 2016, and the estimated study completion date is May 2018. Stratification Treatment assignment will be stratified on the basis of the following criteria: 1.?K?hne Index (low/intermediate/high);17 Eastern Cooperative Oncology Group (ECOG) performance status Number of metastatic sites Alkaline phosphatase (AP) level White cell (WCC) count 2.?Institution; 3.?Prior adjuvant chemotherapy (with or without oxaliplatin). Eligibility criteria Inclusion criteria 1.?Histologically confirmed adenocarcinoma of the colon or rectum; 2.?Advanced or recurrent CRC that is not a candidate for curative resection; Patients with advanced colorectal cancer who received no intervention buy Neratinib expect for surgical procedure (R0 surgery is not included) Patients with recurrent CRC who did not receive any therapy to the site of recurrence. 3.?Age of 20?years or older; 4.?ECOG performance status of 0�C2; 5.?Presence of evaluable lesions as confirmed using CT or MRI and no previous chemotherapy or radiotherapy; 6.?Life BMS-777607 solubility dmso expectancy of longer than 90?days; 7.?No limitation of oral administration; 8.?Adequate organ function according to the following laboratory values obtained within 14?days prior to enrolment in the study (Data recorded nearest to the entry should be referred, and patients who received blood transfusions or haematopoietic growth factors within 14?days prior to the laboratory tests are excluded); 9.?Neutrophils��1500/mm3; 10.?Platelets��10.0��104/mm3; 11.?Haemoglobin��8.0?g/dL; 12.?Total bilirubin��2.0?mg/dL; 13.?Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)��100?IU/L (for patients with liver metastasis,