Trials Annotator

Trial NCT00574275

View at ClinicalTrials.gov

Org. Study IDs: EFC10547
Secondary IDs: 2007-003476-19

Last trial update was posted on 2016-06-07

MeSH Interventions

Aflibercept Gemcitabine

MeSH Conditions

Pancreatic Neoplasms

Other Conditions

Pancreatic Neoplasm

Stopping Reasons

Data Monitoring Committee concluded after a planned interim analysis that aflibercept added to gemcitabine would be unable to demonstrate improved survival

Limitations And Caveats

As the study was terminated due to futility, some changes were made to the planned analyses, and the analyses for the following outcome measures were not performed: Objective Response Rate (ORR) Clinical Benefit

Result Publications

Rougier P, Riess H, Manges R, Karasek P, Humblet Y, Barone C, Santoro A, Assadourian S, Hatteville L, Philip PA. Randomised, placebo-controlled, double-blind, parallel-group phase III study evaluating aflibercept in patients receiving first-line treatment with gemcitabine for metastatic pancreatic cancer. Eur J Cancer. 2013 Aug;49(12):2633-42. doi: 10.1016/j.ejca.2013.04.002. Epub 2013 Apr 30. [PMID: 23642329] [DOI: 10.1016/j.ejca.2013.04.002]

Annotations

Category Annotations

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Intervention Annotations

#	Outdated	Intervention				Condition
#	Outdated	Name		Route	DrugBank ID	Condition