MedTrace Logo

Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma

NCT01208194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-06-20

No results posted yet for this study

Summary

This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.

Conditions

  • Advanced Colorectal Carcinoma

Interventions

DRUG

MGN1703

solution, 60 mg, twice a week, until progression

DRUG

Placebo

solution, 60 mg, twice a week, until progression

Sponsors & Collaborators

  • Mologen AG

    lead INDUSTRY

Principal Investigators

  • Hans-Joachim Schmoll · Klinik für Innere Medizin IV, Universitätsklinikum Halle (Saale)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01208194 on ClinicalTrials.gov