MedTrace Logo

TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)

NCT01362361 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-09-19

No results posted yet for this study

Summary

The purpose of this study:

To explore the comparative effectiveness of BIBF 1120 in terms of :

* Progression-free survival (PFS), objective response, overall survival
* Evaluate and compare safety

Conditions

Interventions

DRUG

mFOLFOX6 + BIBF 1120

mFOLFOX6 + BIBF1120 (2x200 mg/d d1-d14) (repeated every 14 days)

DRUG

mFOLFOX6+placebo

mFOLFOX6 + placebo (2x200 mg/d d1-d14) (repeated every 14 days)

Sponsors & Collaborators

  • GALMED GmbH

    collaborator OTHER

  • Martin-Luther-Universität Halle-Wittenberg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT01362361 on ClinicalTrials.gov