Trial intelligence / Profile preview

Cetuximab + FOLFOXIRI Dose Escalation in mCRC

NCT00422773Phase 2

Key facts

Status
Completed
Start
Jan 2007
Primary completion
Jun 2008
Countries
1
Sponsor
Technische Universität Dresden
Modality
Monoclonal Antibodies
Drugs
KL-140
Conditions
metastatic colorectal cancer (mCRC)
01

Overview

Phase 2, open-label, single-arm trial of KL-140 in metastatic colorectal cancer (mCRC), sponsored by Technische Universität Dresden. Primary endpoints: Maximum Tolerated Dose and Safety. Started Jan 2007; status: completed.

02

Design

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

    Cetuximab combined with Irinotecan, Oxaliplatin, 5-FU, and Folinic Acid.

03

Who it enrols

Patients with non-resectable, histologically confirmed metastatic colorectal cancer (EGFR-positive or negative), WHO performance status 0-1, and adequate organ function. Excludes prior EGFR-targeting therapy or chemotherapy for metastatic disease.

04

Endpoints

Primary

  • Maximum Tolerated Dose

  • Safety

Secondary

  • Feasibility

  • Toxicity

  • Overall Response Rate

  • Resection Rate

  • Progression-Free Survival

  • Overall Survival

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