NCT01822444

ANGIOPREDICT. ICORG 12-16, V3

Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus Fluorouracil/Leucovorin (FOLFOX) in Combination With Bevacizumab (Bvz) in First Line Treatment of Metastatic Colorectal Cancer (CRC) Expressing Mutant K-ras - AC-ANGIOPREDICT

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC). Secondary Objective: 1. To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and 2. To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC.

Detailed description

Study Design: Type of Study: Exploratory, translational, multicenter and multinational Phase II study. Patient Population:All patients from the intent-to-treat population with aCRC or mCRC, (incurable with any conventional multimodality approach) and who fulfil all inclusion and exclusion criteria. Number of Patients: 224 Sample Type: Serial tissue and blood samples will be collected before (week 0), during (week 6, month 3 and 6) and at the end of treatment (month 12).

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Biomarker analysis

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2013-04-02
• Last updated: 2026-04-13

Locations

17 sites across 2 countries: Germany, Ireland