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Phase II Trial to Assess FOLFIRI+Aflibercept Efficacy in Patients With Oxaliplatin-pretreated Metastatic Colorectal Cancer With or Without ACE Polymorphisms

NCT02970916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-04-11

No results posted yet for this study

Summary

The purpose of this study is to assess FOLFIRI+aflibercept efficacy in patients with or without ACE polymorphisms in terms of Progression-free survival (PFS).

Conditions

Interventions

DRUG

FOLFIRI+aflibercept

Aflibercept: 4 mg/kg administered intravenous infusion on day 1 FOLFIRI regimen immediately after aflibercept: Irinotecan:180 mg/m2 intravenous infusion, folinic acid (dl racemic): 400 mg/m2 intravenous infusion, followed by 5-fluorouracil (5-FU): 400 mg/m2 intravenous bolus, followed by 5-FU: 2400 mg/m2 continuous intravenous infusion over 46 hours. \* folinic acid: 400 mg/m² (racémic) or 200 mg/m² (L-form)

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Enrique Aranda, MD-PhD · Hospital Universitario Reina Sofía

  • Auxiliadora Gómez, MD-PhD · Hospital Universitario Reina Sofía

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-05-31
Completion
2018-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970916 on ClinicalTrials.gov