NCT03279289View on ClinicalTrials.gov

Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen

PHASE2CompletedINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

October 25, 2017

Primary Completion Date

February 9, 2023

Study Completion Date

February 9, 2023

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Aflibercept

4 mg/kg administered intravenous infusion on day 1

DRUG

Irinotecan

180 mg/m2 intravenous infusion

DRUG

folinic acid (dl racemic)

400 mg/m2 intravenous infusion

DRUG

5Fluorouracil

400 mg/m2 intravenous bolus

DRUG

5-FU

2400 mg/m2 continuous intravenous infusion over 46 hours

Trial Locations (1)

28046

Spanish Cooperative Group for Digestive Tumour Therapy (TTD), Madrid

Sponsors

Collaborators (1)

Sanofi
All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER

NCT03279289 - Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen | Biotech Hunter | Biotech Hunter