Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer

Phase 3 Completed 1254 enrolled AstraZeneca

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.

Timeline

Start: 2006-11
Primary completion: 2010-03
Completion: 2016-08

Outcome

Missed primary endpoint

release “In March, the HORIZON III study of cediranib plus chemotherapy versus bevacizumab plus chemotherapy did not meet the primary endpoint of PFS.” astrazeneca.com ↗

Publications

Smith JC, Brooks L, Hoff PM, McWalter G, Dearden S, Morgan SR, Wilson D, Robertson JD, Jurgensmeier JM. KRAS mutations are associated with inferior clinical outcome in patients with metastatic colorectal cancer, but are not predictive for benefit with cediranib. Eur J Cancer. 2013 Jul;49(10):2424-32. doi: 10.1016/j.ejca.2013.02.023. Epub 2013 Mar 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cediranib	Small molecule	20 mg	Oral
Subject	Cediranib	Small molecule	30 mg	Oral
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	Leucovorin	Small molecule	—	Intravenous
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous