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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Evaluation of median progression-free survival (PFS) in both treatment groups
Measured on accrual time 3 years
No
Hans-Joachim Schmoll
Principal Investigator
Klinik für Innere Medizin IV, Universitätsklinikum Halle (Saale)
Germany: Paul-Ehrlich-Institut
MGN1703-C02
NCT01208194
June 2010
December 2012
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