Trial intelligence / Profile preview

Prognostic Factors in Advanced CRC Treated With Cetuximab

NCT01068132Phase 2

Key facts

Status
Completed
Start
Apr 2009
Primary completion
Oct 2013
Countries
1
Sponsor
Regione Lombardia
Modality
Monoclonal Antibodies
Drugs
KL-140
Conditions
colorectal cancer (CRC)
01

Overview

Phase 2, open-label, single-arm trial of KL-140 in colorectal cancer (CRC), sponsored by Regione Lombardia. Primary endpoint: Progression Free Survival at 48 months. Started Apr 2009; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Cetuximab + FOLFIRI

    Cetuximab 500 mg/m2 every 2 weeks + FOLFIRI

03

Who it enrols

Adult patients with histologically confirmed KRAS wild-type metastatic colorectal cancer not suitable for curative resection, with no prior chemotherapy for metastatic disease.

04

Endpoints

Primary

  • Progression Free Survival

Secondary

  • Overall Survival

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