Spots Global Cancer Trial Database for Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma
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Trial Identification
Brief Title: Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma
Official Title: Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma With Disease Control After Initial First-line Therapy
Study ID: NCT01208194
Conditions
Study Description
Brief 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.
Detailed Description: The phase 2 study will be conducted in patients with advanced colorectal carcinoma with disease control after first-line standard chemotherapy regimens with oral or intravenous fluoropyrimidines/leucovorin and irinotecan or oxaliplatin combined with a standard dose of bevacizumab lasted between 4.5 and 6 months, whereas the treatment duration with irinotecan or oxaliplatin should not be less than 3 months. Studies confirmed that completely chemotherapy-free intervals can be applicable in patients with advanced colorectal carcinoma who achieved disease control after initial first-line chemotherapy. Those therapy holidays minimize toxicity and unnecessary treatment load, reduce intensity of treatment, allow patients to stay longer on therapy, prevent therapy discontinuations due to toxicity, preserve the ability to re-administer chemotherapy later, and increase quality of life of the patients. The therapy-free interval represents a possibility to evaluate the efficacy of the study drug, MGN1703.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinik fßr Innere Medizin I, Abteilung fßr Klinische Onkologie, Medizinische Universität Wien, Wien, , Austria
Oncology Clinic, Faculty Hospital Olomouc, Olomouc, , Czech Republic
Service de CancĂŠrologie Digestive, Institut de CancĂŠrologie Gustave Roussy, Villejuif, , France
Onkologischer Schwerpunkt am Oskar-Helene-Heim, Berlin, , Germany
Klinik fßr Innere Medizin IV, Onkologie/ Hämatologie/ Hämostaseologie, Universitätsklinikum Halle (Saale), Halle, , Germany
Kath. Marienkrankenhaus GmbH, Allgemeine Onkologie, Hamburg, , Germany
Schwerpunktpraxis fßr Hämatologie und Onkologie, Magdeburg, , Germany
Klinik fßr Innere Medizin, Klinik fßr Hämatologie, Onkologie, Immunologie, Universitätsklinikum Giessen und Marburg GmbH, Marburg, , Germany
Medizinische Klinik, Abteilung fßr Onkologie, Hämatologie Immunologie, Rheumatologie und Pulmologie Universität Tßbingen, Immuntherapie, Station 65 Med. Klinik Abt. II, Tßbingen, , Germany
State Institution "Russian Scientific Oncology Center named after N.N. Blokhin RAMN", Moscow, , Russian Federation
Non-state health care institution "Central Clinical Hospital No. 2 named after N.A. Semashko OAO "RZHD", Moscow, , Russian Federation
Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom
Contact Details
Name: Hans-Joachim Schmoll
Affiliation: Klinik fßr Innere Medizin IV, Universitätsklinikum Halle (Saale)
Role: PRINCIPAL_INVESTIGATOR
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