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Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

NCT01479465 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2019-04-17

Study results available
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Summary

The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

Conditions

Interventions

BIOLOGICAL

Simtuzumab

SIM administered via intravenous infusion over 30 minutes

DRUG

Placebo to match SIM

Placebo to match SIM administered via intravenous infusion over 30 minutes

DRUG

Leucovorin

l-Leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours

DRUG

Irinotecan

Irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes

DRUG

Fluorouracil

Fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours

Sponsors & Collaborators

Principal Investigators

  • Zung Thai, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-10-31
Completion
2015-02-28

Countries

  • United States
  • France
  • Germany
  • Italy
  • Poland
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479465 on ClinicalTrials.gov