Study of IMC-11F8 in Participants With Colorectal Cancer

Sponsor
Eli Lilly and Company
Study ID
NCT00835185
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMC-11F8 (necitumumab) — BIOLOGICAL
    IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1
  • Oxaliplatin — DRUG
    Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1
  • Folinic acid (FA) — DRUG
    FA 400 mg/m² IV infusion bolus injection
  • 5-FU — DRUG
    5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours

Study Details

The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).

Key Dates

Start date
Aug 31, 2007
Status verified
Dec 2015
Primary completion
Jan 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IMC-11F8 (necitumumab) /mFOLFOX-6 regimen
    Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)

Primary Outcome Measure

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response ) [ Time Frame: Up to 30 Months ]

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