CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled
Drug / intervention
Ramucirumab (IMC-1121B) +3 morebiological
Likely dose
Ramucirumab (IMC-1121B) 8 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01286818
NCT01286818Phase 1Completed
CompareCT.gov

A Phase 1b Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B) Drug Product in Japanese Subjects With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

Eli Lilly and Company·interventional·Posted Jan 31, 2011·Updated Oct 6, 2014

In Brief

A Phase 1 clinical trial evaluating Ramucirumab (IMC-1121B), Irinotecan, and 2 other interventions for Colorectal Carcinoma. Completed, enrolled 6 participants across 3 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Carcinoma
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2011
Enrollment StartFeb 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.4 years ago

Interventions

Ramucirumab (IMC-1121B)biological

Ramucirumab (IMC-1121B): Intravenous (IV) infusions, 8 milligrams per kilogram (mg/kg) every 2 weeks

Irinotecandrug

IV Infusion, 180 milligrams per square meter (mg/m²) every 2 weeks

levofolinatedrug

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