A Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B)

Sponsor
Eli Lilly and Company
Study ID
NCT01286818
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ramucirumab (IMC-1121B) — BIOLOGICAL
    Ramucirumab (IMC-1121B): Intravenous (IV) infusions, 8 milligrams per kilogram (mg/kg) every 2 weeks
  • Irinotecan — DRUG
    IV Infusion, 180 milligrams per square meter (mg/m²) every 2 weeks
  • levofolinate — DRUG
    IV infusion, 200 mg/m² every 2 weeks
  • 5-Fluorouracil (5-FU) — DRUG
    400 mg/m² bolus followed by a 2400 mg/m² continuous infusion, every 2 weeks

Study Details

The primary objective of this study is to investigate the safety and tolerability of the anti-vascular endothelial growth factor receptor-2 (anti-VEGFR-2) monoclonal antibody Ramucirumab (IMC-1121B) in combination with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) in Japanese participants with advanced colorectal carcinoma (CRC).

Key Dates

Start date
Feb 28, 2011
Status verified
Oct 2014
Primary completion
Feb 29, 2012
Completion
Mar 31, 2012

Study Design

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

Arms

  • Experimental: FOLFIRI plus Ramucirumab (IMC-1121B)

Primary Outcome Measure

Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period [ Time Frame: Day 1, Cycle 1 through Day 1, Cycle 3 (1 cycle=14 days) ]

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