{"entity":{"id":"nct00399035","kind":"trial","name":"Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer","aka":["HORIZON II"],"tldr":"A phase 3 trial of Cediranib, FOLFOX, Leucovorin, Oxaliplatin, Fluorouracil and CAPOX in Colorectal cancer, run by AstraZeneca, completed.","summary":"Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT00399035 by AstraZeneca, with 1254 participants recorded, started 2006-11 and reaching its primary completion in 2010-03. Interventions recorded: Cediranib, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), XELOX (Capecitabine and Oxaliplatin), Cediranib Placebo. Conditions recorded: Metastatic Colorectal Cancer.\n\nLinked to the drug Cediranib because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00399035","url":"https://clinicaltrials.gov/study/NCT00399035"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["cediranib","folfox","leucovorin","oxaliplatin","fluorouracil","capox"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00399035","phase":"3","setting":"A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.","sponsor":"AstraZeneca","started":"2006-11","yearReported":2012,"enrolled":1254,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival","primary":true,"unit":"months","arms":[{"name":"Cediranib 20 mg","n":502,"value":8.6,"note":"IQR 5.5 to 12.1; Figures from the ClinicalTrials.gov results section (first posted 2012-10-30), not from a publication"},{"name":"Placebo","n":358,"value":8.2,"note":"IQR 4.1 to 11.1"}],"source":"https://clinicaltrials.gov/study/NCT00399035?tab=results"},{"endpoint":"Overall Survival","primary":true,"unit":"months","arms":[{"name":"Cediranib 20 mg","n":502,"value":19.7,"note":"IQR 11.0 to 36.1; Figures from the ClinicalTrials.gov results section (first posted 2012-10-30), not from a publication"},{"name":"Placebo","n":358,"value":18.9,"note":"IQR 11.0 to 28.9"}],"source":"https://clinicaltrials.gov/study/NCT00399035?tab=results"},{"endpoint":"Overall Response Rate","unit":"participants","arms":[{"name":"Cediranib 20 mg","n":502,"value":254,"note":"Figures from the ClinicalTrials.gov results section (first posted 2012-10-30), not from a publication"},{"name":"Placebo","n":358,"value":178}],"source":"https://clinicaltrials.gov/study/NCT00399035?tab=results"}]},"route":"/trials/nct00399035/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"drug":[{"id":"capox","kind":"drug","name":"CAPOX (capecitabine, oxaliplatin)","route":"/drugs/capox/"},{"id":"cediranib","kind":"drug","name":"Cediranib","route":"/drugs/cediranib/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}